MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CHISEL HANDLE; CHISEL, BONE, SURGICAL

Model Number	399.54
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Occupation: initial reporter is a synthes sales consultant.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 on (b)(6) 2019, the chisel handle bolt was missing.It is unknown where the issue was discovered.Procedure and patient involvement are unknown.This report is for a chisel handle.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.H3, h4, h6:device history lot: part: 399.540.Lot: 9311648.Manufacturing site: bettlach.Release to warehouse date: 20.Jan.2015.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Only top level of the device history record reviewed as sub-components are not lot tracked.H3, h6: investigation summary complaint summary: it was reported on an february 15,2019, the chisel handle bolt was missing.It is unknown where the issue was discovered.Procedure and patient involvement are unknown.Service & repair evaluation: the customer reported that device was missing a handle bolt.The repair technician reported the device required further testing at the vendor due to failed operation.Damaged coupler is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item was scrapped and will be forwarded to customer quality.The evaluation was confirmed.Flow: visual (appearance not as expected) visual inspection: the returned instrument was received with the screw m6x6 missing.The device overall shows surface wear consistent with use.The received condition does agree with the complaint description.Document/specification review: no design or manufacturing defect or deficiency was observed during the investigation.From the drawings in can be seen that the screw m6x6 and is needed for the device to function as intended and therefore a conclusive determination has been reached.A device history review, was performed for the returned instrument¿s lot number, no ncrs and no mrrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.Investigation conclusion: the complaint condition was confirmed.A definitive root cause for the given complaint condition could not be determined from the provided information.However, it is likely that the complaint condition occurred due to incorrect handling at the cleaning process or on a previous surgery.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.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: CHISEL HANDLE
• Common Device Name: CHISEL, BONE, SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8405032
• Report Number: 2939274-2019-56887
• Device Sequence Number: 11227223
• Product Code: EML
• UDI-Device Identifier: 10886982202895
• UDI-Public: (01)10886982202895
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 02/15/2019

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: 399.54
• Device Catalogue Number: 399.54
• Device Lot Number: 9311648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Initial Date Received by Manufacturer: 02/15/2019
• Supplement Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 04/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1