MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE; GUIDE

Catalog Number 03.010.044

Device Problems Device-Device Incompatibility (2919); Naturally Worn (2988)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient information is not available for reporting.Date of event is unknown.Device is an instrument and is not implanted/explanted.The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.A review of the device history records has been requested and is currently pending completion.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 on an unknown date, patient underwent an unknown surgery.During the procedure, the cannulated connecting screw for standard insertion handle got jammed in the tibial nail.The connecting screw was unable to loosen from the tibial nail, requiring a new tibial nail and connecting screw.It was unclear if the connecting screw had stripped.After the surgery was over, the connecting bolt was successfully disconnected from the nail after several attempts.No patient consequence was reported.It was unknown if there was a surgical delay.Patient outcome was not unknown.This report is for one (1) cannulated connecting screw for standard insertion handle.(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.Device history record (dhr) review: part # 03.010.044; synthes lot # u137733; supplier lot # u137733; release to warehouse date: 03aug2011; supplier: (b)(4).No nonconformance records (ncrs) 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.Investigation summary: customer quality investigation: the following investigations were performed: device interaction functional & damage: visual appearance not as expected: device condition: visual inspection performed at customer quality (cq) under 5x magnification on the given device observed worn threads.No new issues were observed on other portions of the device.Furthermore, functional inspection performed on the device with the returned nail showed no issues threading the connecting screw to the nail.However, the insertion handle that is used along with the nail in insertion process was not returned.The given complaint condition does not agree with the given complaint condition and therefore the given condition was not able to be confirmed.However, with the worn conditions identified the overall complaint condition was confirmed.Dimensional analysis and document/specification review: relevant drawings for the returned instrument were reviewed (both from the time of manufacture and present revision) and no design issues were identified.Dimensional inspection was not performed as the observed worn condition is due to post manufacture damage.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.No ncrs were generated during production.Therefore, no design and manufacture issues were identified that would contribute to complaint condition.Conclusion: a definitive root cause for the given device condition could not be determined from the provided information.Furthermore, any possible construct assembly and disassembly issues that could have occurred were not able to be confirmed as the insertion handle was not returned.However, it is likely that any unintended off-axis screwing during usage could have contributed to this complaint condition.The overall complaint condition 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.

• Brand Name: CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE
• Type of Device: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7710490
• MDR Text Key: 114716245
• Report Number: 2939274-2018-53018
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 10886982067166
• UDI-Public: (01)10886982067166
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.044
• Device Lot Number: U137733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Date Manufacturer Received: 08/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1