MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM/6.5MM STEPPED DRILL BIT LARGE QC/485MM; BIT, DRILL

Catalog Number	03.010.078
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 (b)(6) as follows: it was reported that on (b)(6) 2021, during the procedure the tip of the drill/reamer broke off.The broken tip was removed from the femoral head.This report involves one (1) 4.5mm/6.5mm stepped drill bit large qc/485mm.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.H3, h6: a product investigation was conducted.Visual inspection: the reamer ø4.5/6.5 l484 f/hip screws lfn (p/n: 03.010.078, lot #:f-24595) was returned and received at us cq.Upon visual inspection, it was observed that the distal tip was broken and the broken fragment was not returned.No other issues were observed with the returned device.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Yes, the device received was broken.Hence confirming the allegation.Investigation conclusion: the complaint condition is confirmed for the reamer ø4.5/6.5 l484 f/hip screws lfn (p/n: 03.010.078, lot #:f-24595).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.H3, h4, h6: a device history record (dhr) review was conducted: part # 03.010.078, lot # f-24595, release to warehouse date: 18 may 2018, manufacturer: sphinx , no ncr's were generated during production.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.

• Brand Name: 4.5MM/6.5MM STEPPED DRILL BIT LARGE QC/485MM
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11967053
• Report Number: 8030965-2021-04727
• Device Sequence Number: 14383793
• Product Code: HTW
• UDI-Device Identifier: 07611819765702
• UDI-Public: (01)07611819765702
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2021

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: 03.010.078
• Device Lot Number: F-24595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 08/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1