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

Catalog Number	399.098
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is not available for reporting.Unknown when device malfunctioned.Device is an instrument and is not implanted/explanted.Complainant device is not expected to be returned for manufacturer review/investigation.Reporter phone number: (b)(6).Reporter address not provided for reporting.A device history record (dhr) review was requested and is not possible as reported serial number (b)(4) does not match to article number 399.098.Without a valid serial/lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 the reduction forceps broke.The instrument was used in human but it is unknown if it broke intra-operatively or pre-operatively.No further information provided.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
A device history record (dhr) review was performed for part number: 399.098, synthes lot number: 4157045, supplier lot number: n5009: release to warehouse date: 17-aug-2000, supplier: (b)(4): no non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.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): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6944193
• Report Number: 9612488-2017-10518
• Device Sequence Number: 10987812
• Product Code: HTD
• UDI-Device Identifier: 07611819221000
• UDI-Public: (01)07611819221000
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 10/03/2017

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/03/2017
• Supplement Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 10/12/2017
• Supplement Report FDA Received Date: 11/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1