MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TOMOFIX OSTEOTOMY CHISEL 10MM WIDTH; CHISEL, SURGICAL INSTRUMENT

Model Number	397.992
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a synthes employee.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 during a routine incoming inspection of a loaner set on an unknown date, the tomofix osteotomy chisel was observed broken.There was no known hospital or patient involvement.This report is for a tomofix osteotomy chisel 10mm width.This is report 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: a review of the device history record.Device history lot: part: 397.992, lot: l647392, manufacturing site: bettlach, release to warehouse date: 19.March 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: investigation summary complaint summary: it was reported that on an unknown date, during a routine incoming inspection of a loaner set, the tomofix osteotomy chisel was observed broken.There was no known hospital or patient involvement.Flow: damage.Visual inspection: the tomofix osteotomy chisel 10 mm width (part # 397.992, lot # l647392, mfg # 19-mar-2018) was received at us cq with the distal end of the chisel jagged and not straight.The edge of the chisel is deformed.This is not consistent with the reported complaint condition.Therefore, the complaint is not confirmed.Dimensional inspection: dimensional analysis was not performed since the chisel edge is deformed due to post-manufacturing damage.Document/specification review: the following drawing(s) was reviewed; tomofix osteotomy chisel: se.420709 rev b.Conclusion: there is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: TOMOFIX OSTEOTOMY CHISEL 10MM 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: 8749437
• Report Number: 2939274-2019-58941
• Device Sequence Number: 2039087
• Product Code: FZO
• UDI-Device Identifier: 10886982201270
• UDI-Public: (01)10886982201270
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2019

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: 397.992
• Device Catalogue Number: 397.992
• Device Lot Number: L647392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1