MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TOMOFIX OSTEOTOMY CHISEL 20MM WIDTH; CHISEL, SURGICAL INSTRUMENT

Model Number	397.994
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records has been requested.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 on (b)(6) 2019, during a corrective osteotomy of a distal femur using a tomofix set,  the back end of the chisel broke off.The surgeon made the first cut for the osteotomy using a saw blade and then inserted the tomofix osteotomy chisel into the cut.He began hitting the chisel with a mallet attempting to complete the osteotomy and after several blows, the chisel broke.There were no fragments generated form the broken device.There was no surgical delay.Procedure was successfully completed with no patient consequence.   concomitant medical products reported: unknown saw blade (part # unknown, lot# unknown, quantity # 1); unknown mallet (part # unknown, lot# unknown, quantity # 1).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: h3, h4, h6: device history records review was completed for part: 397.994, lot: l080921.Manufacturing location: bettlach, release to warehouse date: oct 26, 2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.The hardness value was confirmed to meet the specification with no non-conformance noted.H3

• Brand Name: TOMOFIX OSTEOTOMY CHISEL 20MM WIDTH
• Common Device Name: CHISEL, SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8493601
• Report Number: 2939274-2019-57375
• Device Sequence Number: 1538185
• Product Code: FZO
• UDI-Device Identifier: 10886982201294
• UDI-Public: (01)10886982201294
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2019

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 Model Number: 397.994
• Device Catalogue Number: 397.994
• Device Lot Number: L080921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Initial Date Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 05/06/2019
• Patient Sequence Number: 1
• Patient Age: 12 YR
• Patient Weight: 126