MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 1.0MM DRILL BIT/K-WIRE ATTCHMT FOR THREADED HOLE/75MM; BIT, DRILL

Catalog Number	03.130.100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2020
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.A device history record (dhr) review was conducted: part: 03.130.100, lot: f-23805, manufacturing site: (b)(4), supplier: (b)(4), release to warehouse date: 14.Mar.2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.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 during the surgical procedure on (b)(6) 2020, one (1) 1.0mm drill bit was broken and one (1) 1.0mm drill bit was bent.No fragments remained in the patient.Procedure was successfully completed with no other medical intervention.No further information provided.Concomitant device reported: lock strut pl 1.3 8ho obliq-angl le l19 (part # 02.130.159, lot # l483064, quantity 1).This report is for one (1) 1.0mm drill bit/ k-wire attchmt for threaded hole/ 75mm.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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: updated data: e1.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: 1.0MM DRILL BIT/K-WIRE ATTCHMT FOR THREADED HOLE/75MM
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10638931
• Report Number: 8030965-2020-07760
• Device Sequence Number: 3650203
• Product Code: HTW
• UDI-Device Identifier: 07611819682986
• UDI-Public: (01)07611819682986
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2020

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: 03.130.100
• Device Lot Number: F-23805
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/19/2020
• Supplement Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LOCK STRUT PL 1.3 8HO OBLIQ-ANGL LE L19