MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC WIRE TIGHTENER WITH HANDLE & TWO PEGS 240MM; MISC ORTHO SURGICAL INSTR

Catalog Number	391.21
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Supplier lot number: 2242660.A review of the device history records has been requested.The device has been 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 an unknown date, a wire tightener handle was found broken when the facility opened a tray.There was no procedure and patient involvement.This report is for one (1) wire tightener with handle & two pegs 240mm.This is report 1 of 1 for complaint (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.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.Part 391.210, synthes lot number: 5492841, supplier lot number: 2242660: manufacturing site: bettlach.Release to warehouse date: january 16, 2007.The device history record shows this lot of device was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.A service and repair evaluation was completed: the customer reported the handle was found broken.The repair technician reported the handle was broken in pieces.Handle cracked/broken 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.A product investigation was completed: visual inspection of the returned device performed at customer quality (cq) confirmed the condition of breakage, which agrees with the reported complaint condition.The handle is broken in three pieces.The entire device shows superficial surface wear.It was also observed that the two peg components are missing (were not returned).The returned device was manufactured in january 2007 and is approximately 12 years old.The relevant design drawings were reviewed during this investigation.No product design issues or discrepancies were observed during this investigation.Dimensional inspection could not be performed due to the post manufacturing damage.There is no indication that material properties contributed to the returned 12-year-old handle breaking.A definitive root cause for the handle breaking on the returned 12-year-old instrument could not be determined based on the provided information.The most likely possible causes are cumulative wear and/or rough handling for 12 years of service.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified as a result of this evaluation.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: WIRE TIGHTENER WITH HANDLE & TWO PEGS 240MM
• 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: 8127153
• Report Number: 2939274-2018-55233
• Device Sequence Number: 16709641
• Product Code: LXH
• UDI-Device Identifier: 10886982198228
• UDI-Public: (01)10886982198228
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 11/15/2018

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: 391.21
• Device Lot Number: 5492841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2018
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 11/23/2018; 01/09/2019
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 12/10/2018; 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1