MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; WIRE,SURGICAL

Device Problem Mechanical Jam (2983)

Patient Problem No Code Available (3191)

Event Date 03/01/2018

Event Type  Injury  

Manufacturer Narrative

Patient information not available for reporting.Date of event reported as (b)(6) 2018, exact date is not known.This report is for an unknown cable/wire/unknown lot.Part and lot numbers are unknown; udi number is unknown.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.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 Description

(b)(6) reported that during an open reduction internal fixation (orif) procedure of the right femur, as the surgeon was tightening a cable with a cable tensioner, the cable got "stuck" and the surgeon could not release (or advance) the cable from the tensioner.The surgeon cut the cable and used a wire instead to complete the procedure.There was no patient harm and no surgical time delay reported.This report is for one (1) cable/wire this is report 2 of 2 for (b)(4).

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.A product investigation was conducted.The following investigation flow was performed: device interaction / functional.Visual inspection performed at customer quality (cq) confirmed the condition of a cable stuck inside a tensioner, which agrees with the reported complaint condition.The cable appears to have been manually cut.The devices were sent to the supplier and were able to be separated.No issues were identified with either device upon disassembly.No new malfunctions have been identified.The product code and lot number for the device are not know.Therefore, a device history review was unable to be completed.Relevant drawings for the returned device were not able to be reviewed as the product code and part family were not able to be identified.Dimensional analysis of the cable determined that the thickness of the cable measured 1.71mm (ca592) at customer quality.As the specific product family was unable to be identified, no risk document review and occurrence rate is able to be performed.While no definitive root cause could be determined it is possible that a lack of lubrication on the cable tensioner caused it to malfunction, or the cable was frayed/bent prior to insertion.This complaint is confirmed however no product design issues or manufacturing discrepancies were identified during this investigation.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.

Event Description

Concomitant device reported: 2.5mm drill tip guide wire 200mm (part# 310.243, lot# unknown, quantity 1).

Manufacturer Narrative

The device was received and the product evaluation is in progress.No conclusion can be drawn.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.

• Type of Device: WIRE,SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7398055
• MDR Text Key: 104412688
• Report Number: 2939274-2018-51459
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2018
• Date Manufacturer Received: 06/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention