MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TENSIONER; MISC ORTHO SURGICAL INSTR

Model Number	03.311.001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	09/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 an orthopedic procedure, the tensioner would not release an unknown wire and ended up broken.The surgeon had to manually twist it off and used the backup tensioner.There were no fragments generated.The broken device was removed easily without additional intervention.There was a surgical delay of 5 minutes.The procedure was successfully completed.The patient was not affected and there were no patient consequences reported.This complaint involves two (2) devices.This report is for one (1) tensioner.This is report is 1 of 2 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.Not applicable as no additional intervention required during procedure.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.
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.Visual inspection: the clamp jaws as well as the conical sleeve of the universal chuck are badly damaged.The shaft of the t-handle has come loose.The overall appearance of the front part of the chuck is in very used condition.Functional test / dimensional inspection: could not be performed due to the damage incurred.Document/specification review: the manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.A review of the manufacturing drawings and the corresponding dcos showed that the same deviations as with these complaints were examined in detail by the development department.A corrective action was that the torque value for tightening the reaction fork, component 50167454, has been increased from 5 nm to 23 nm.Further, the functional issues have been addressed and investigated under eu capa in 2013.Summary: the complaint condition is confirmed and consistent with the reported condition as the reaction fork was identified as loose and, therefore, the function of the tensioner can no longer be guaranteed.Replication of the complaint condition is not applicable as the device is already mating device was not received.The complaint condition is a result of the design but it has already been addressed by dco and capa.The current design was determined to be suitable for the intended use when employed and maintained as recommended.No production errors were detected during the manufacturing inspection.The risk assessment was found to adequately address the complaint condition.A corrective and/or preventative action is proposed or already launched.Device history: supplier, part: 03.311.001, lot: 1542289, manufacturing site: haegendorf, release to warehouse date: 23.Aug.2006.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Synthes: part: 03.311.001, lot: 1586977, manufacturing site: haegendorf, release to warehouse date: 29.Nov.2006.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: TENSIONER
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9164277
• Report Number: 2939274-2019-61271
• Device Sequence Number: 16649060
• Product Code: LXH
• UDI-Device Identifier: 10886982077769
• UDI-Public: (01)10886982077769
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2019

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: 03.311.001
• Device Catalogue Number: 03.311.001
• Device Lot Number: 1586977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Initial Date Received by Manufacturer: 09/20/2019
• Supplement Date Received by Manufacturer: 11/19/2019; 01/13/2020
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 12/16/2019; 01/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention