MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC REDUCTION FORCEPS WITH POINTS RATCHET 200MM

Model Number	399.98
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No known patient involvement reported.Date of event is unknown.Device is an instrument and is not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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
(b)(6) reported following: it was reported that two large reduction forceps were found broken in the sterile processing department and require replacement.Damaged through regular usage.There was no known patient involvement reported.This report is for one (1) reduction forceps with points ratchet 200mm.This is report 2 of 2 for (b)(4).

• Brand Name: REDUCTION FORCEPS WITH POINTS RATCHET 200MM
• Common Device Name: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE: SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7250871
• Report Number: 2939274-2018-50546
• Device Sequence Number: 16382970
• Product Code: HTD
• UDI-Device Identifier: 10886982203168
• UDI-Public: (01)10886982203168(10)LOT#UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/18/2018

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 Model Number: 399.98
• Device Catalogue Number: 399.98
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/18/2018
• Initial Report FDA Received Date: 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1