MAUDE Adverse Event Report: SYNTHES TUTTLINGEN REDUCTION FORCEPS WITH SERRATED JAW 240MM-SPEED LOCK

Catalog Number	399.051
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Patient information is not available for reporting.Patient¿s exact age at time of event and date of birth are unknown.The patient¿s estimated age is late 60¿s early 70¿s.Device is an instrument and is not implanted/explanted.The subject device has been received and is currently undergoing investigation.A device history record review was performed for the subject device lot.Manufacturer: synthes (b)(4).Date of manufacture: may 7, 2009.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.(b)(4).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 while clamping the plate to the bone, for an open reduction and internal fixation (orif) of a right distal tibia, the tip of one of the points on the reduction forceps broke off.The surgeon did not realize that the tip on the reduction forceps had broken off until final x-rays were completed.As it was unknown to the surgeon that the tip had broken off, the procedure continued.The patient was successfully implanted with an anterior lateral distal tibia plate and screws.The reduction forceps performed its intended function of clamping the plate to the bone.When final x-rays were taken, the surgeon noted the presence of the broken tip on the medial side of the distal tibia.The surgeon used an instrument/forceps to retrieve the broken tip.Retrieval did not require an additional incision.The surgery was delayed approximately 4-5 minutes to retrieve the broken tip.Another intraoperative x-ray was taken to ensure that the broken tip was retrieved.The broken tip was discarded.The procedure was completed successfully and the patient¿s condition was reported as stable.The reduction forceps broke on the bone side not the plate side.On the lateral side of the tibia was the plate and on the medial side of the plate was where the tip of the forceps broke.There was no issue with the plate.Concomitant device reported: anterior lateral distal tibia plate (quantity of 1).This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product development investigation was completed.A visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed as part of this investigation.This complaint is confirmed.When viewing the returned device with the speedlock oriented upward, the bottom distal tip of the forceps has sheared off.The sheared off tip fragment would be approximately 9mm in length (calipers (b)(4)) with reference to product drawing.The material composition at the fracture surface appears homogeneous when viewed under 5x magnification.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already broken.Relevant drawings were reviewed during this investigation.No product design issues or discrepancies were observed.The 399.051 reduction forceps are an instrument routinely used with the 105.90 bone forceps set to aid in fracture reduction of bones and bony fragments.A root cause could not be definitively determined given the unknown circumstances at the time of the break and over the lifetime of the device.No new, unique or different patient harms were identified as a result of this evaluation.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 WITH SERRATED JAW 240MM-SPEED LOCK
• Common Device Name: FORCEPS
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• MDR Report Key: 6400770
• Report Number: 9680938-2017-10040
• Device Sequence Number: 19108019
• Product Code: HTD
• UDI-Device Identifier: 10886982202253
• UDI-Public: (01)10886982202253(10)T934783
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 399.051
• Device Lot Number: T934783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/15/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2017
• Supplement Report FDA Received Date: 04/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN ANTERIOR LATERAL DISTAL TIBIA PLATE, QTY 1
• Outcome Attributed to Adverse Event: Required Intervention