MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STANDARD INSERTION HANDLE; MISC ORTHO SURGICAL INSTR

Catalog Number 03.010.045

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 05/23/2018

Event Type  malfunction  

Manufacturer Narrative

This information 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.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history records review has been requested.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 (b)(6) 2018, during a femoral nail case, the protection sleeve would not slide through the insertion handle hole.This called a small surgical delay as another tray had to be used.There was no harm to the patient and surgery was completed successfully.This report is for a standard insertion handle.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Corrected data: phone number, patient code.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 there was a four (4) minute surgical delay.Reportedly there were no fragments generated and no additional intervention was needed to complete the procedure.

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 records (dhr) review: part no.: 03.010.045; lot no.: 1564984; manufacturing location: haegendorf; release to warehouse date: october 10, 2006; 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 the product that would contribute to this complaint condition.Investigation summary: customer quality investigation: the following investigations were performed: device interaction / functional: visual inspection: visual inspection performed at customer quality (cq) of the returned insertion handle observed nicked and raised surfaces across mating edge of the insertion handle with the protection sleeve which agree with the reported complaint condition.No new issues were identified other than minor surface errors that will not affect the product functionality.Functional inspection: functional inspection performed on the returned device showed that the mating devices (insertion handle and protection sleeve) stuck during the insertion.The protection sleeve was observed to be stuck at its distal portion and further insertion of the protection sleeve was not possible.The complaint condition was able to be replicated and the complaint 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 analysis performed at the cannulation for protection sleeve accepted the max gage pin of diameter 11.92 mm (gp:29) which falls out of specification of 12 mm to 12.036 mm per drawings.The out of specification is due to the post manufacture wear in the form of nicks and raised edges.A device history review performed for the returned instrument¿s lot number showed no ncrs, material review records (mrrs) or complaint-related issues which may have contributed to the complaint condition.Conclusion: while no definitive root cause could be determined, it is possible that the device encountered unintended forces with such as unintended hammering during usage could have contributed to complaint condition.During the investigation, no product design issues or discrepancies 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.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: STANDARD INSERTION HANDLE
• Type of Device: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7611173
• MDR Text Key: 111484106
• Report Number: 2939274-2018-52529
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886982067173
• UDI-Public: (01)10886982067173
• 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,Followup
• Report Date: 05/23/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.045
• Device Lot Number: 5373786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Initial Date Manufacturer Received: 05/23/2018
• Initial Date FDA Received: 06/18/2018
• Supplement Dates Manufacturer Received: 06/18/2018; 07/05/2018
• Supplement Dates FDA Received: 07/13/2018; 07/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1