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

Catalog Number	391.884
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Part 391.884, lot p247358: release to warehouse date: july 29, 2016.Supplier: (b)(4).No non-conformance reports (ncr's) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.A product investigation was completed: the provisional tensioning device was received for investigation.The device is in a worn condition consistent with routine use and servicing.The etches are slightly faded, but still completely legible.The hex coupling is undamaged.No visible damage that would impact functionality was able to be identified.The devices were manually operated and each was found to correctly open and close without any issues.There was no difficulty actuating the device and no issues with the internal locking mechanism was identified.The report of difficulty actuating was unable to be confirmed and the complaint condition was not able to be confirmed.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.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 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 testing after the case was completed the surgeon and an associate attempted to feed the leftover unknown cable through two (2) provisional tensioning device, but it was unable to get the cable lock or tensioner holder to lock onto the unknown cable.There was no patient involvement.Concomitant device reported: cable/wire: (part/lot unknown, quantity unknown) this report is for a provisional tensioning device.This is report 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.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
Additional concomitant device: cable tensioner (part/lot unknown, quantity unknown).

• Brand Name: PROVISIONAL TENSIONING DEVICE
• 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: 8411526
• Report Number: 2939274-2019-56928
• Device Sequence Number: 14035347
• Product Code: LXH
• UDI-Device Identifier: 10886982198365
• UDI-Public: (01)10886982198365
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 01/13/2019

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 Catalogue Number: 391.884
• Device Lot Number: P247358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Initial Date Received by Manufacturer: 01/13/2019
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1