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

Catalog Number	399.098
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no known reported patient involvement associated with the complained event.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Facility address is not provided for reporting.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested and is currently pending completion.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 europe reports an event in (b)(6) as follows: it was reported that a soft lock part is broken.No patient was involved.This report is for one (1) reduction forceps w/ serrated jaw-medium handle-soft ratchet.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Device history record (dhr) not available as device is older than 17 years.At this time, the manufacturing documents for instruments had to be stored for 10 years.This was according to filing and archiving of specification documents, which were in place till august 2014.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 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-MEDIUM HANDLE-SOFT RATCHET
• Common Device Name: FORCEPS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7700926
• Report Number: 8030965-2018-55156
• Device Sequence Number: 1618457
• Product Code: HTD
• UDI-Device Identifier: 07611819221000
• UDI-Public: (01)07611819221000
• 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,Followup
• Report Date (Section B): 06/28/2018

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: 399.098
• Device Lot Number: N5013
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 09/07/2018
• Patient Sequence Number: 1