MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ENDPIECE WITH DOUBLE JOINT; TRACTION, APPARATUS, NON-POWERED

Model Number 394.44

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2019

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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

It was reported that during an orthopedic procedure on (b)(6) 2019, the locking clip broke off the chain, rendering the end piece with double joint unusable.The procedure was successfully completed with no surgical delay reported.There was no patient consequence.This report is for an endpiece with double joint.This is report 1 of 1 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.H3, h4, h6: visual inspection of the returned device performed at customer quality (cq) identified the condition of missing components.The clip, chain and 2 ring components are missing from the returned device.While no breakage occurred, it is most likely the that ring component that secures the clip and chain to the pin was disrupted and released its hold on the pin.The 394.440 endpiece with double joint is a reusable instrument in the large-distractor tibia system used an alternative to the fracture table.No product design issues or discrepancies were observed during this investigation.Investigation conclusion: a definitive assignable root cause for the missing components could not be determined based on the provided information.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.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 dhr not available as device is older than 20 years.At this time the manufacturing documents for instruments had to be stored for 10 years.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: ENDPIECE WITH DOUBLE JOINT
• Type of Device: TRACTION, APPARATUS, NON-POWERED
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8420413
• MDR Text Key: 138795424
• Report Number: 2939274-2019-56951
• Device Sequence Number: 1
• Product Code: HST
• UDI-Device Identifier: 10886982199720
• UDI-Public: (01)10886982199720
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 394.44
• Device Catalogue Number: 394.44
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Date Manufacturer Received: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1