MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH OUTER SLEEVE FOR DRILL SLEEVE SMALL F/SCREW TARGETING CLAMP; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	03.211.465
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is synthes sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device history lot : part number: 03.211.465, lot number: t164851, manufacturing site: (b)(4), release to warehouse date: 12-feb-2019.A review of the device history records 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 (b)(6) reports an event as follows: it was reported that on an unknown date in an academic conference, the sales rep could not insert the drill sleeve(2.5mm) to the outer sleeve.No further information is available.This report is for outer sleeve for drill sleeve small f/screw targeting clamp.This is report 1 of 2 for (b)(4).

• Brand Name: OUTER SLEEVE FOR DRILL SLEEVE SMALL F/SCREW TARGETING CLAMP
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9750500
• Report Number: 8030965-2020-01369
• Device Sequence Number: 1367717
• Product Code: FZX
• UDI-Device Identifier: 07611819614895
• UDI-Public: (01)07611819614895
• 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): 02/01/2020

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: 03.211.465
• Device Lot Number: T164851
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2020
• Initial Report FDA Received Date: 02/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1