MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH REDUCTION FORCEPS W/SERRATED JAW-LARGE HANDLE-SOFT RATCHET

Catalog Number	399.124
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
Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: initial reporter is synthes sales consultant.  a review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date, the grasping part of the reduction forceps was discovered broken.It is unknown how the issue was discovered.It is unknown if there were patient and surgical involvement.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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.Device history lot.Part: 399.124.Lot: 5029.Manufacturing site: (b)(4).Dhr not available as device is older than 15 years.At this time the manufacturing documents for instruments had to be stored for 10 years.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: REDUCTION FORCEPS W/SERRATED JAW-LARGE HANDLE-SOFT RATCHET
• Common Device Name: FORCEPS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8332969
• Report Number: 8030965-2019-60934
• Device Sequence Number: 1650322
• Product Code: HTD
• UDI-Device Identifier: 07611819221048
• UDI-Public: (01)07611819221048
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2019

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: 399.124
• Device Lot Number: 5029
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 02/12/2019
• Supplement Report FDA Received Date: 03/26/2019
• Patient Sequence Number: 1