MAUDE Adverse Event Report: SYNTHES TUTTLINGEN REDUCTION FORCEPS WITH POINTS RATCHET 130MM

Catalog Number	399.97
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.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Manufacturing date: 12-feb-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 100 parts of the lot were checked 100% for critical features and for function at the final inspection on 11-feb-2014 and found to be conforming.No ncrs were generated during production.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 the tip of the reduction forceps with points ratchet is broken.It is not known how the device was broken.No patient involvement was reported.This report is for one (1) reduction forceps with points ratchet.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: subject device has been received and a product development investigation was completed.The 399.97 lot number t997551 reduction forceps is an instrument routinely used in the 1.5mm lcp modular mini fragment system were returned and reported that the tip is broken.The device was returned and reported that the tip is broken.This condition is confirmed; while the device is not broken and no material is missing, one of the tips has been entirely flattened giving it that appearance.It is likely that over three years of consistent use and possible rough handling during surgery or sterile processing has led to this complaint condition.The device was manufactured in 2/2014 and is over three years old.The balance of the returned device is in otherwise fairly good condition with only some superficial wear was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.This complaint condition was likely caused by over three years 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, dhr review, and drawing review were performed as part of this investigation.This complaint is confirmed.Device 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 WITH POINTS RATCHET 130MM
• Common Device Name: FORCEPS
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• MDR Report Key: 6755534
• Report Number: 9680938-2017-10125
• Device Sequence Number: 13493557
• Product Code: HTD
• UDI-Device Identifier: 10886982203144
• UDI-Public: (01)10886982203144(10)T997551
• 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): 07/19/2017

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: 399.97
• Device Lot Number: T997551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2017
• Initial Date Received by Manufacturer: 07/19/2017
• Supplement Date Received by Manufacturer: 08/10/2017
• Initial Report FDA Received Date: 07/31/2017
• Supplement Report FDA Received Date: 08/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1