MAUDE Adverse Event Report: SYNTHES GMBH 2.0MM CANNULATED DRILL BIT/QC 150MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	310.221
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient underwent an operation to treat left patella fracture.Surgeon planned to insert 2 headless compression screws in parallel manner across fracture site.It was difficult trajectory.The first guide wire was inserted without issue.Second guide wire was inserted in a convergent manner and impacted to the first guide wire, resulted in breakage of the tip of the second guide wire within bone.Surgeon decided not to remove it.A cannulated drill bit tip was inserted over the guide wire and reaming was done.However, the tip was broken off within bone probably also due to the difficult trajectory.It was also decided not to remove.The cannulated screwdriver was used to insert the headless compression screw, the screw driver's tip broke outside the bone and was able to be retrieved.
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
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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: added: d9 and d10 h3, h6: the product was not returned to medtech orthopaedics, however photos were provided for review.The photo investigation revealed that 310.221, 2.0mm cannulated drill bit/qc 150mm had broken tip.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.The investigation was not able to confirm the allegation of embedded device as no x-rays were provided to evaluate the condition.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the 2.0mm cannulated drill bit/qc 150mm would contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed to component failure and 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 review part # 310.221 lot # f-18213 manufacturing site: werk villmergen logistik release to warehouse date: 12.Aug.2015 supplier: (b)(4) expiration date: n/a.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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: h3, h6: the product was not returned to medtech orthopaedics, however photos were provided for review.The photo investigation revealed that 310.221, 2.0mm cannulated drill bit/qc 150mm had broken tip.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.The investigation was not able to confirm the allegation of embedded device as no x-rays were provided to evaluate the condition.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the 2.0mm cannulated drill bit/qc 150mm would contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed to component failure and 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 review part # 310.221 lot # f-18213 manufacturing site: werk villmergen logistik release to warehouse date: 12.Aug.2015 supplier: (b)(4) expiration date: n/a.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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: h3, h4, h6: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the 2.0mm cannulated drill bit/qc 150mm was broken from the distal tip.No post operative x-rays were provide, therefore the embedded allegation cannot be confirmed.The broken fragment was not returned for evaluation.However, the fracture surface was examined, and no signs were found to indicate any problems with the material.The observed condition of the device is consistent with a component failure that was caused by exposure to unintended forces like overtightening the device while assemblance; or by using the device in a misaligned position.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 not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the 2.0mm cannulated drill bit/qc 150mm would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to component failure, and 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 review (dhr): part # 310.221 lot # f-18213 manufacturing site: sphinx werkzeuge ag supplier: (b)(4) release to warehouse date: 12 aug 2015 expiration date: na.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.0MM CANNULATED DRILL BIT/QC 150MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: elba bello ; 1302 wrights lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22340869
• Report Number: 8030965-2025-06467
• Device Sequence Number: 18407238
• Product Code: HWE
• UDI-Device Identifier: 07611819086074
• UDI-Public: (01)07611819086074(10)18213
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 310.221
• Device Lot Number: F-18213
• 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: 06/09/2025
• Supplement Date Received by Manufacturer: 07/02/2025; 07/17/2025; 07/21/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 07/02/2025; 07/18/2025; 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE Ø1.1 W/THREAD-TIP W/TROCAR L15; SCRDRIVER SHAFT CANN T8 W/COLOUR-MARKING
• Patient Sex: Unknown