MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RADIOLUCENT INSERTION HANDLE FRN; ROD,FIXATION,INTRAMEDULLARY

Model Number 03.033.001

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2018

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter is synthes sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 on (b)(6) 2018, after the successful completion of an intramedullary nailing of the right femur, the driving cap became cold-welded onto the radiolucent insertion handle and could no longer be taken apart.There was no patient consequence.This report is for one (1) radiolucent insertion handle frn.This is report 1 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.Additional narrative: concomitant medical products.Device evaluated by mfr, device manufacture date: device history records review was completed for part: 03.033.001, lot: l551412.Manufacturing location: haegendorf, release to warehouse date: nov 17, 2017.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device evaluated by mfr: product investigation was completed.Visual inspection performed at customer quality (cq) noted that the distal threads of a driving cap (03.010.523) had broken off and were lodged in the insertion handle.The balance of the device shows surface wear consistent with use and which would not impact the functionality.No new issues were identified during the inspection.Based on the reported complaint description it is not possible to definitively determine if external factors (use error, misuse/abuse, etc.) impacted the complaint condition.The received condition is consistent with the allegation of inability to disassemble the driving cap from the insertion handle as such the complaint is confirmed.The complaint condition was able to be replicated as the threads were unable to be removed from the insertion handle.Relevant drawings were reviewed during investigation and no design issues were noted.No dimensional inspection of the relevant features, proximal threads, was able to be completed as a broken fragment of the driving cap was lodged in the hole and unable to be retrieved.A visual inspection, document/specification review and dimensional inspection were performed as part of this investigation.Driving cap distal threads were unable to be retrieved from the complaint device, thus confirming the complaint.No product design or manufacturing issues were identified, and no new malfunctions were identified either.Based upon these results, 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: RADIOLUCENT INSERTION HANDLE FRN
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8155873
• MDR Text Key: 130327800
• Report Number: 2939274-2018-55369
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982271051
• UDI-Public: (01)10886982271051
• Combination Product (y/n): N
• PMA/PMN Number: K172157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/21/2018

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 Model Number: 03.033.001
• Device Catalogue Number: 03.033.001
• Device Lot Number: L551412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Initial Date Manufacturer Received: 11/21/2018
• Initial Date FDA Received: 12/12/2018
• Supplement Dates Manufacturer Received: 01/09/2019
• Supplement Dates FDA Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 19 YR