MAUDE Adverse Event Report: SYNTHES GMBH 2.8MM PERCUTANEOUS DRILL BIT F/LCP® PL QC/200MM/100MM CALIB

Catalog Number	324.214
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
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.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Device report from synthes reports an event in colombia as follows: it was reported that on (b)(6) 2024, during the procedure the drill broke.The distal end of the drill remains inside the patient.This report involves one (1) 2.8mm percutaneous drill bit f/lcp® pl qc/200mm/100mm calib.This is report 1 of 1 for (b)(4).
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.H10: additional narrative: h3, h4, h6: product code: 324.214, lot: 5630p72: a manufacturing record evaluation was performed for the finished device and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on april 20, 2023.Manufacturing site: jabil bettlach.Device was used for treatment, not diagnosis.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: device history review (dhr): a manufacturing record evaluation was performed for the finished device.Product code: 324.214.Lot number: 5630p72.The product was released on: 20-apr-2023.Manufacturing site:jabil bettlach.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 corrected: e4 h3, h4, h6: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the drill bit ø2.8 w/scal l200/100 3flute f/ was found broken from the beginning of the fluted tip.The fracture surface was examined, and no damage related to material issues was observed.Additionally, the fractured fragment was not returned for examination and no postoperative x-rays were provided to confirm the embedded device.Therefore, the reported condition can be partially confirmed.The observed condition of the device was consistent with a component failure that was caused by exposure to unintended forces.This could have originated from a misalignment of the 2.8 mm drill guide with the plate resting of the bone, causing the tip to contact the plate instead of the bone, resulting in the potential fracture.A dimensional inspection was performed as it is not applicable to the complaint condition.A functional evaluation was not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the drill bit ø2.8 w/scal l200/100 3flute f/ 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 review (dhr): a manufacturing record evaluation was performed for the finished device product code: 324.214 lot number: 5630p72 it was electronically reviewed and no nonconformances/manufacturing irregularities were identified during the manufacturing process.The product was released on: 20-apr-2023 manufacturing site:jabil bettlach if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.8MM PERCUTANEOUS DRILL BIT F/LCP® PL QC/200MM/100MM CALIB
• Common Device Name: DRILL BIT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19013792
• Report Number: 8030965-2024-04290
• Device Sequence Number: 3825608
• Product Code: HTW
• UDI-Device Identifier: 07611819807952
• UDI-Public: (01)07611819807952(10)5630P72
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 324.214
• Device Lot Number: 5630P72
• 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: 03/14/2024
• Supplement Date Received by Manufacturer: 04/12/2024; 10/01/2024; 12/10/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 04/30/2024; 10/08/2024; 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown