MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PIN REV DOME DRILL 30MM; DRILLS

Catalog Number	227430800
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, a total hip arthroplasty surgery was performed.The surgery was carried out using corail & pinnacle instruments and materials.Following the implantation of the acetabular shell with ¿ pinnacle acetabular shell sector ii with porocoat 50mm od, the surgeon proceeded, in accordance with the standard procedure, to drill through the bone via the holes in the acetabular shell using the drill bit pin rev dome drill 30mm.During the drilling process, it was found that the aforementioned drill bit fractured, and the larger part remained inside the patient's bone.The operation was completed with a significant delay, with the broken piece of the drill bit remaining inside the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: according to the information received, "on wednesday, (b)(6), 2025, at the [hospital], a total hip arthroplasty surgery was performed by orthopedic surgeon [doctor], in the presence of colleague.The surgery was carried out using corail & pinnacle instruments and materials.Following the implantation of the acetabular shell with ¿ pinnacle acetabular shell sector ii with porocoat 50mm od, the surgeon proceeded, in accordance with the standard procedure, to drill through the bone via the holes in the acetabular shell using the drill bit pin rev dome drill 30mm, (attached photograph).During the drilling process, it was found that the aforementioned drill bit fractured, and the larger part remained inside the patient's bone.(attached radiograph).The operation was completed with a significant delay, with the broken piece of the drill bit remaining inside the patient." the product was not returned to j&j medtech orthopaedics; however photos were provided for review.See attachment (f, viber_image_(b)(6)_2025_09-29-15-087).The radiographic investigation revealed that a fragment of the tip of the drill is logged in the patient's bone.Therefore, embedded condition can be confirmed.Additionally, a photo of the pin rev dome drill 30mm without the tip was provided.The broken condition could be consistent with multiple uses under extreme eccentric loading resulting in premature bending or failure of the drill bit, however, because the fragment was not returned, a proper investigation into the potential cause of the fracture is not possible with the photographic evidence provided.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the pin rev dome drill 30mm would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the date code (pg0605) provided is not a valid finished goods lot number.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, "on wednesday, (b)(6) 2025, at the [hospital], a total hip arthroplasty surgery was performed by orthopedic surgeon [doctor], in the presence of colleague.The surgery was carried out using corail & pinnacle instruments and materials.Following the implantation of the acetabular shell with ¿ pinnacle acetabular shell sector ii with porocoat 50mm od, the surgeon proceeded, in accordance with the standard procedure, to drill through the bone via the holes in the acetabular shell using the drill bit pin rev dome drill 30mm, (attached photograph).During the drilling process, it was found that the aforementioned drill bit fractured, and the larger part remained inside the patient's bone.(attached radiograph).The operation was completed with a significant delay, with the broken piece of the drill bit remaining inside the patient." the product was not returned to j&j medtech orthopaedics; however, photos were provided for review.See attachment (f , viber_image_(b)(6)).The radiographic investigation revealed that a fragment of the tip of the drill is logged in the patient's bone.Therefore, embedded condition can be confirmed.Additionally, a photo of the pin rev dome drill 30mm without the tip was provided.The broken condition could be consistent with multiple uses under extreme eccentric loading resulting in premature bending or failure of the drill bit, however, because the fragment was not returned, a proper investigation into the potential cause of the fracture is not possible with the photographic evidence provided.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the pin rev dome drill 30mm would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the date code (pg0605) provided is not a valid finished goods lot number.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary according to the information received, "on wednesday, (b)(6) 2025, at the [hospital], a total hip arthroplasty surgery was performed by orthopedic surgeon [doctor], in the presence of colleague.The surgery was carried out using corail & pinnacle instruments and materials.Following the implantation of the acetabular shell with ¿ pinnacle acetabular shell sector ii with porocoat 50mm od, the surgeon proceeded, in accordance with the standard procedure, to drill through the bone via the holes in the acetabular shell using the drill bit pin rev dome drill 30mm, (attached photograph).During the drilling process, it was found that the aforementioned drill bit fractured, and the larger part remained inside the patient's bone.(attached radiograph).The operation was completed with a significant delay, with the broken piece of the drill bit remaining inside the patient." the product was returned to medtech orthopaedics for evaluation.Visual examination of returned device revealed the tip broken from pin rev dome drill 30mm.Broken fragment was not returned for evaluation.The investigation was able to confirm the embedded allegation as x-rays were provided to evaluate the condition.This condition is consistent with multiple uses under extreme eccentric loading resulting in premature bending or failure of the drill bit, however taking in consideration the age of the device, the potential cause can be attributed to end of life.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the pin rev dome drill 30mm would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to end of life, and it has been determined that no corrective and/or preventative action is required.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the date code (pg0605) provided is not a valid finished goods lot number.Corrected: h3.

• Brand Name: PIN REV DOME DRILL 30MM
• Common Device Name: DRILLS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22631633
• Report Number: 1818910-2025-13040
• Device Sequence Number: 18374659
• Product Code: HTW
• UDI-Device Identifier: 10603295109150
• UDI-Public: (01)10603295109150(10)PG0605
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 227430800
• Device Lot Number: PG0605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/10/2025
• Supplement Date Received by Manufacturer: 08/07/2025; 08/14/2025; 09/03/2025; 10/02/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 08/08/2025; 08/15/2025; 09/04/2025; 10/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2005
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown