MAUDE Adverse Event Report: SYNTHES GMBH 1.1MM DRILL BIT/K-WIRE ATTCHMT FOR THREADED HOLE/70MM; BIT, DRILL

Catalog Number	03.130.200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Without a valid lot number the device history records review could not be completed.Complainant device is expected to be returned for manufacturer review/investigation.Initial reporter is j&j company representative.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 europe reports an event in (b)(6) as follows: it was reported that a fracture occurred during surgery.This report is for one (1) 1.1mm drill bit/k-wire attchmt for threaded hole/70mm.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4) h3, h6: investigation summary investigation flow: damage visual inspection: the drill bit ø1.1 l70/39 f/core hole (p/n: 03.130.200, lot #: f-23440) was returned and received at us cq.Upon visual inspection, it was observed the tip of the device was broken.No other issues were identified with the returned device.Device failure/defect was identified.Document/specification review: no design issues or discrepancies were identified.Complaint was confirmed.Investigation conclusion: this complaint could be confirmed for the returned device.No definitive root cause could be determined based on the provided information.No new, unique, or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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.Device history lot part: 03.130.200 lot: f-23440 manufacturing site: selzach supplier: (b)(4) release to warehouse date: jan.18, 2018 device history review a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: 1.1MM DRILL BIT/K-WIRE ATTCHMT FOR THREADED HOLE/70MM
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11999988
• Report Number: 8030965-2021-04945
• Device Sequence Number: 3411190
• Product Code: HTW
• UDI-Device Identifier: 07611819690585
• UDI-Public: (01)07611819690585
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2021

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: 03.130.200
• Device Lot Number: F-23440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 08/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1