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

Model Number	03.311.001
Medical Device Problem Codes	Use of Device Problem (1670); Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes rep.A review of the device history record has been requested.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 an unknown date, a wire tightener was not functioning properly and it looked like that an unknown wire was stuck inside.Procedure and patient involvement are still unknown.This complaint involves two (2) devices.This report is for one (1) tensioner.This report is 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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.D10: device returned.H11: 1.Manufacturing site provided and updated for reporting.H3, h6: 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.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.The tensioner (p/n: 03.311.001, lot #: 1442584) was returned and received disassembled from the reaction fork upper and lower at us cq.Upon visual inspection, an unknown wire was stuck inside.The external threads of the reaction fork, upper component and the internal threads of the tensioning assembly were stripped.There were scratches on the device but has no impact on the functionality of the device.No other issues were identified with the returned device.The customer reported a wire tightener was not functioning properly and it looked like that an unknown wire was stuck inside.The repair technician reported the wire stuck inside the tensioner.Damaged component is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.No dimensional inspection can be performed due to post-manufacturing damage.The complaint condition is confirmed for the tensioner (p/n: 03.311.001, lot #: 1442584).There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot part: 03.311.001.Lot: 1442584.Manufacturing site: hägendorf.Release to warehouse date: 02.February 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. SURGICAL ORTHO INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9520713
• Report Number: 2939274-2019-62790
• Device Sequence Number: 16257899
• Product Code: LXH
• UDI-Device Identifier: 10886982077769
• UDI-Public: (01)10886982077769
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2019

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: 1442584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 01/21/2020; 02/27/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 02/11/2020; 03/02/2020
• Patient Sequence Number: 1