MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH REDUCTION FORCEPS WITH POINTS MEDIUM HANDLE-SOFT RATCHET

Catalog Number	399.092
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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: 399.092.Lot: 5945482.Manufacturing site: (b)(4).Release to warehouse date: 28.May.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 synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the forceps lock device was broken and unable to hold.No further information is available.This report is for one (1) reduction forceps with points medium handle-soft ratchet.This is report 1 of 1 for (b)(4).

• Brand Name: REDUCTION FORCEPS WITH POINTS MEDIUM HANDLE-SOFT RATCHET
• Common Device Name: FORCEPS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10308457
• Report Number: 8030965-2020-05119
• Device Sequence Number: 825561
• Product Code: HTD
• UDI-Device Identifier: 07611819220966
• UDI-Public: (01)07611819220966
• 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): 07/03/2020

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: 399.092
• Device Lot Number: 5945482
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/03/2020
• Initial Report FDA Received Date: 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1