MAUDE Adverse Event Report: SYNTHES TUTTLINGEN LARGE COMPRESSION FORCEPS WITH SPEED LOCK

Catalog Number	03.118.002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement associated with the device breakage.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).Manufacturing date: december 05, 2014.Review of the device history record of (b)(4) showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.A review of inspection records and certifications, confirm that the components and final product met inspection records.All parts of the lot were checked 100% for critical and important features and for function at the final inspection.No non-conformance reports were generated during production.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 (b)(4) reports an event in (b)(6) as follows: it was reported that the spring on the compression forceps was identified as being broken when packing the set after being sterilized.The instrument had not been used for the previous procedure; it was in a set that had been opened for use.There was no patient involvement associated with the device breakage.This is report 1 of 1 for com-(b)(4).
Additional Manufacturer Narrative
Complainant part is no longer expected to be returned for manufacturer review/investigation.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: LARGE COMPRESSION FORCEPS WITH SPEED LOCK
• Common Device Name: FORCEPS
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• MDR Report Key: 6273940
• Report Number: 9680938-2017-10008
• Device Sequence Number: 50311
• Product Code: HTD
• UDI-Device Identifier: 07611819521377
• UDI-Public: (01)07611819521377(10)T108825
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2017

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: 03.118.002
• Device Lot Number: T108825
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/05/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2017
• Supplement Report FDA Received Date: 02/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1