MAUDE Adverse Event Report: SYNTHES TUTTLINGEN CHISEL BLADE 16MM; CHISEL,SURGICAL INSTRUMENT

Catalog Number	399.56
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.The subject device is not expected to be returned to the synthes manufacturer for evaluation.The investigation could not be completed; no conclusion could be drawn, as no product was received.The subject device was reportedly discarded.A device history record review was performed for the subject device lot.Manufacturer: synthes (b)(4).Date of manufacture: feb 24, 2016.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.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 during an osteotomy procedure of the pelvis on (b)(6) 2017, a chisel broke.It was reported that as the surgeon was trying to complete one of his cuts by using the chisel to cut through the pelvis, as he twisted the chisel, it snapped.The chisel broke around the handle so that the blade was one large piece.It was reported that the broken piece was easily retrieved and the surgeon completed the procedure with an osteotome.Another chisel was readily available if needed but was not used.There was a five (5) minute delay to retrieve the broken part and no fragments remained in the patient.The patient was implanted with three (3) pelvic screws.The surgery was completed successfully and the patient was reported to be in good condition.Concomitant device: mallet (part #unknown, lot #unknown, quantity 1), osteotome (part #unknown, lot #unknown, quantity 1).This report is 1 of 1 for (b)(4).

• Brand Name: CHISEL BLADE 16MM
• Common Device Name: CHISEL,SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• MDR Report Key: 6318061
• Report Number: 9680938-2017-10017
• Device Sequence Number: 19065629
• Product Code: FZO
• UDI-Device Identifier: 10886982202925
• UDI-Public: (01)10886982202925(10)T132790
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/17/2017

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: 399.56
• Device Lot Number: T132790
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2017
• Initial Report FDA Received Date: 02/09/2017
• 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 MALLET, QTY 1; UNKNOWN OSTEOTOME DEVICE, QTY 1
• Patient Age: 16 YR
• Patient Weight: 65