MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PROX REAMING GUIDE DIA 16 MM; DRILL GUIDES

Catalog Number	230774016
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during intraoperative deflection of the proximal reamer guide size 16, there were difficulties in screwing the inner rod of the reamer guide into the inserter (to attach the reamer guide size 16 firmly to the instrument).It was not possible to unscrew it; the inner rod was bent and the tip was broken off (fragment did not fall into the site).No patient harm.Surgery time extended by several attempts to remove the reaming guide size 16, which was still in the humeral shaft, using the customer's own alternative instruments in order to insert the original implant.Surgery delay 20 minutes.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy orthopaedics is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy orthopaedics has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy orthopaedics or its employees that the report constitutes an admission that the device, depuy orthopaedics, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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).Investigation summary = > according to the information received, " during intraoperative deflection of the proximal reamer guide size 16, there were difficulties in screwing the inner rod of the reamer guide into the inserter (to attach the reamer guide size 16 firmly to the instrument).It was not possible to unscrew it; the inner rod was bent and the tip was broken off." the product was not returned to medtech orthopaedics; however photos were provided for review.See attachment ¿(b)(4).Photo.¿ the photo investigation did not reveal that prox reaming guide dia 16 mm (230774016) had any assembly or disassembly issue.Review of provided photo shows the device however without having actual device for evaluation reported condition cannot be confirmed and cause remains undetermined.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 not confirmed as the observed condition of the prox reaming guide dia 16 mm would not contribute 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 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 = > the device lot number is unknown, therefore a¿device history review could not be performed.¿ if the lot/serial number becomes available, the record will be re-assessed.Added: b5.
Event or Problem Description
Please confirm if there is any allegation against the 2 unk insertion devices -> as per sales rep the answer is "no".
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: d4 (lot), d9, h4.Corrected: d4 (primary udi #).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, " during intraoperative deflection of the proximal reamer guide size 16, there were difficulties in screwing the inner rod of the reamer guide into the inserter (to attach the reamer guide size 16 firmly to the instrument).It was not possible to unscrew it; the inner rod was bent and the tip was broken off.".The product was not returned to medtech orthopaedics; however, photos were provided for review.The photo investigation did not reveal that prox reaming guide dia 16 mm (230774016) had any assembly or disassembly issue.Review of provided photo shows the device however without having actual device for evaluation reported condition cannot be confirmed and cause remains undetermined.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 not confirmed as the observed condition of the prox reaming guide dia 16 mm would not contribute 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 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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information provided: "instruments of (b)(4) were used again.During intraoperative deflection of the proximal reamer guide size 16, there were difficulties in screwing the inner rod of the reamer guide into the inserter (to attach the reamer guide size 16 firmly to the instrument).It was not possible to unscrew it; the inner rod was bent and the tip was broken off (fragment did not fall into the site).No patient harm.Surgery time extended by several attempts to remove the reaming guide size 16, which was still in the humeral shaft, using the customer's own alternative instruments in order to insert the original implant.Surgery delay 20 min".The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection revealed the square adapter surface of the prox reaming guide dia 16 mm with several deep scratches and delamination patterns.Additionally, the overall device surface exhibited signs of usage.Scratches and delamination observed can be consistent with other tools and hard edges coming in contact with the device; or by assembling the device in a misaligned position with its mating device (holder for reaming guides).Properly handling and attention to the approved use of the device diminishes the risk of failure.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was performed for the prox reaming guide dia 16 mm using the returned holder for reaming guides as mating device.Functional test revealed that although the device was able to be assemble, certain resistance was presented while both assembly and disassembly with its mating component, confirming the reported event.Potential cause can be traced to a component failure as a consequence of the damage observed on the prox reaming guide dia 16 mm adapter surface.A manufacturing record evaluation was performed for the finished device (b)(4) lot number, and no non-conformances nor manufacturing irregularities were identified.The overall complaint was confirmed as the observed condition of the prox reaming guide dia 16 mm 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: 1) quantity manufactured: (b)(4).2) date of manufacture: 26-mar-2015.3) any anomalies or deviations identified in dhr: no.4) expiry date: n/a.5) ifu reference: (b)(4).A manufacturing record evaluation was performed for the finished device (b)(4) lot number, and no non-conformances nor manufacturing irregularities were identified.Device history review: a manufacturing record evaluation was performed for the finished device (b)(4) lot number, and no non-conformances nor manufacturing irregularities were identified.H11 additional narrative: corrected: h3.

• Brand Name: PROX REAMING GUIDE DIA 16 MM
• Common Device Name: DRILL GUIDES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21432190
• Report Number: 1818910-2025-02893
• Device Sequence Number: 4606611
• Product Code: PHX
• UDI-Device Identifier: 10603295116189
• UDI-Public: (01)10603295116189(10)5245925
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K170748
• 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
• 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: 230774016
• Device Lot Number: 5245925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2025
• Supplement Date Received by Manufacturer: 02/25/2025; 03/11/2025; 03/28/2025; 05/19/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 02/27/2025; 03/12/2025; 03/31/2025; 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2015
• 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