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	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2022
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.Reporter is a j&j employee.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device photo.Visual analysis of the photo revealed that there was no damage or defects with the drill bit ø1.1 l70/39 f/core hole.Reported condition cannot be confirmed due to poor quality evidence and complaint device is not shown clearly.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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for the drill bit ø1.1 l70/39 f/core hole.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.A device history record (dhr) review was conducted: part: 03.130.200, lot: f-23440, manufacturing site: (b)(4).Supplier: sphinx werkzeuge ag.Release to warehouse date: 18.Jan.2018.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.
Event or Problem Description
Device report from depuy synthes reports an event in (b)(6) as follows: it was reported that during a procedure on (b)(6), 2022, the 0.8 l 40/16 drill bit split and the 1.1 l 70/39 drill bit was not cutting.Procedure was successful.The procedure was not delayed by this event.There was no other medical intervention required.Patient outcome is reported as okay.No further information provided.This report is for one (1) 1.1mm drill bit/k-wire attchmt for threaded hole/70mm.This is report 2 of 2 for complaint (b)(4).

• 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
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 14146692
• Report Number: 8030965-2022-02539
• Device Sequence Number: 12325691
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2018
• 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