MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 6.0MM/5.0MM THREADED DRILL SLEEVE-SHORT; MISC ORTHO SURGICAL INSTR

Catalog Number	395.921
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is jnj representative.Investigation summary: product was not returned.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 history lot: part number: 395.921, lot number: 3l03396, manufacturing site: (b)(4), release to warehouse date: april 09, 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's 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 (b)(6) reports an event as follows: it was reported on an unknown date and unknown procedure that it was difficult to insert pin.It was unknown when it¿s occurred.It was unknown if the procedure completed successfully.The patient outcome is unknown.This complaint involves one (1) device.This report is for (1) 6.0mm/5.0mm threaded drill sleeve-short.This is report 1 of 1 for (b)(4).

• Brand Name: 6.0MM/5.0MM THREADED DRILL SLEEVE-SHORT
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10616772
• Report Number: 8030965-2020-07636
• Device Sequence Number: 16753979
• Product Code: LXH
• UDI-Device Identifier: 07611819739055
• UDI-Public: (01)07611819739055
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2020

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: 395.921
• Device Lot Number: 3L03396
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 10/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1