MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 130 DEG AIMING ARM; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 03.037.013

Device Problem Device-Device Incompatibility (2919)

Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510k: this report is for an unk - guides/sleeves/aiming: aiming arm /unknown lot.Part and lot numbers are unknown; udi number is unknown.Synthes employee.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.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) 2019, during the proximal femoral nailing system (tfna) on a patient left hip fracture, a distal targeting device on a short tfna did not work on the nail.It had to manipulate and had to spend the aiming arm and the handle in equipment back in to have it replace and evaluated to see if there was anything going on about.It is unknown if there a surgical delay.Procedure and patient outcome were unknown.This is report 3 of 3 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.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 devices reported: aiming arm locking device (part# 03.037.015, lot# 3l89040, quantity# 1).

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.Flow: device interaction/functional.Visual inspection: both hybrid insertion handle and 130 deg aiming arm were received in assembled condition.Both devices were able to be separated.Upon visual inspection, no damage was noticed on the device.The device was received intact.Functional testing: both device were able to be re-assembled and tightened properly.A complete functional test in effort to replicate the reported complaint condition could not be performed at cq as nail, other mating device was not returned.Dimensional inspection: it was not performed as no damage found to the returned device as observed during the visual inspection.Conclusion: this complaint was not able to be confirmed or replicated and no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.Unfortunately, we are not able to determine the exact reason for this occurrence, but we have to assume that during the operation an application error may have taken place.During the investigation no unidentified product design/manufacturing 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.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot part: 03.037.013-us, lot: 4l94574, manufacturing site: (b)(4), release to warehouse date: aug 05, 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: 130 DEG AIMING ARM
• 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: 9371777
• MDR Text Key: 194658869
• Report Number: 2939274-2019-62382
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• 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: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.037.013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Date Manufacturer Received: 12/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AIMING ARM LOCKING DEVICE
• Patient Age: 40 YR