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

Catalog Number	399.124
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted / explanted.Device history records review was completed for part# 399.124, lot# t118169.Manufacturing location: (b)(4), manufacturing date: jan 14, 2016.No non conformance reports were generated during production.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 features and for function at the final inspection on jan 14, 2016.The device was received and the product evaluation is in progress.No conclusion can be drawn.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
It was reported that the tip of the reduction forceps was found to be broken by hospital staff.It is unknown when the tip broke, but it did not occur during surgery.The tip is not available for return.This report is for one (1) reduction forceps.This is report 1 of 1 for com-(b)(4).
Additional Manufacturer Narrative
A product development investigation was performed.The 399.124, lot number t118169 reduction forceps was returned and reported to have been found broken.This complaint condition was likely caused by over a year of consistent use and possible rough handling during surgery or sterile processing; however, this complaint is not likely a result of any design or manufacturing related deficiency.A visual inspection, device history record (dhr) review, and drawing review were performed as part of this investigation.This complaint is confirmed.Per technique guide, the 399.124 reduction forceps are an instrument routinely used in the pediatric lcp plate system.The device was returned and reported to have been found broken.This condition is confirmed; the distal tip of one of the jaws has broken off and was not returned.The device was manufactured in 01/2016 and is over a year old.The balance of the returned device is in otherwise fairly good condition with only some markings and visible wear.Relevant drawing was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.The condition of the returned device does agree with the complaint description.Whether the complaint condition for this device can be replicated is not applicable for this condition.Upon review of the device history record, no non conformance reports (ncrs) germane to the complaint condition were generated during the production of this device.It is likely that over a year of consistent use and possible rough handling during surgery or sterile processing has led to this complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the 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-LARGE HANDLE-SOFT RATCHET
• Common Device Name: FORCEPS
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• MDR Report Key: 6260281
• Report Number: 9680938-2017-10005
• Device Sequence Number: 937220
• Product Code: HTD
• UDI-Device Identifier: 10886982202390
• UDI-Public: (01)10886982202390(10)T118169
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2016

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: T118169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/18/2017
• Supplement Report FDA Received Date: 02/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1