MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RADIOLUCENT RECON AIMING ARM FOR EXPERT LFN; ROD, FIXATION, INTRAMEDULLARY

Model Number 03.010.482

Device Problems Device Slipped (1584); Device-Device Incompatibility (2919)

Patient Problem No Code Available (3191)

Event Date 08/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional medical/surgical intervention required and change in surgical plan: unable to proceed with the recon nail locking option).The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing 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

It was reported that during a recon nail surgery on (b)(6) 2019, the cannulas of two (2) radiolucent recon aiming arm for expert lateral femoral nail (lfn) were a little bit loose inside.The four (4) guide wires missed the recon nail hole posterior and anterior by quite a bit and because of it surgeon was unable to proceed with the recon nail locking option.Even after locking the largest gold cannula into the radiolucent aiming arm, the surgeon and the sales rep felt as though there was some "wiggle" room or a little bit of toggle that could be the cause of the guidewires missing the nail's recon holes.A few millimeters of toggle could create a misplaced guide wire.There was a surgical delay of 5-8 minutes.The surgery was completed using the same aiming arms and the standard locking option for the patient.It was an impending fracture distally down the shaft of the femur, so nothing was compromised.The patient outcome is unknown.Concomitant devices reported: unknown recon nail (part# unknown, lot# unknown, quantity# 1).This report is for one (1) radiolucent recon aiming arm.This is report 1 of 6 for complaint (b)(4).

Event Description

Updated event description (additional information) it was reported that during a recon nail surgery on (b)(6) 2019, the cannulas of two (2) radiolucent recon aiming arm for expert lateral femoral nail (lfn) were a little bit loose inside.The guide wires four (4) was missing the recon nail hole posterior and anterior by quite a bit and was unable to proceed with the recon nail locking option because of it.Even after locking the largest gold cannula into the radiolucent aiming arm, the surgeon and the sales rep felt as though there was some "wiggle" room or a little bit of toggle that could be the cause of the guidewires missing the nail's recon holes.A few millimeters of toggle could create a misplaced guide wire the sales rep commented that the instruments have gotten loose over the years as they have been used.There was a surgical delay of 5-8 minutes.The surgery was completed using the same aiming arms and the standard locking option for the patient.It was an impending fracture distally down the shaft of the femur, so nothing was compromised.The patient outcome is unknown.Concomitant devices reported: unknown recon nail (part# unknown, lot# unknown, quantity# 1).This complaint involves six (6) devices.

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.A review of the device history record device history lot , part number: 03.010.482, lot number: t993311, manufacturing site: tuttlingen, release to warehouse date: 27-jul-2013.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.Investigation summary background: updated event description (additional information).It was reported that during a recon nail surgery on (b)(6) 2019, the cannulas of two (2) radiolucent recon aiming arm for expert lateral femoral nail (lfn) were a little bit loose inside.The guide wires four (4) was missing the recon nail hole posterior and anterior by quite a bit and was unable to proceed with the recon nail locking option because of it.Even after locking the largest gold cannula into the radiolucent aiming arm, the surgeon and the sales rep felt as though there was some "wiggle" room or a little bit of toggle that could be the cause of the guidewires missing the nail's recon holes.A few millimeters of toggle could create a misplaced guide wire the sales rep commented that the instruments have gotten loose over the years as they have been used.There was a surgical delay of 5-8 minutes.The surgery was completed using the same aiming arms and the standard locking option for the patient.It was an impending fracture distally down the shaft of the femur, so nothing was compromised.The patient outcome is unknown.Concomitant devices reported: unknown recon nail (part# unknown, lot# unknown, quantity# 1).This complaint involves six (6) devices.Investigation flow: functional/device interaction visual inspection: the radiolucent recon aiming arm for expert lfn (p/n 03.010.482 lot t993311) was received with one of the cam locks fallen off, the fallen off cam lock was returned.No other issues were identified with the returned components of the device.Functional inspection functional testing could not be completed as the mating guide wires/other mating instruments were not received for evaluation.The cam locks were tested with gage pins, along with the dimensional inspection and fully functional.All dimensions are conforming.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Conclusion: the complaint condition is unconfirmed for the radiolucent recon aiming arm for expert lfn (p/n 03.010.482 lot t993311) as no defect or deformities were identified during the investigation that may have contributed to the complaint condition.No dimensional non-conformities were observed that may have caused any mating devices to be loose.A non related defect of a fallen off cam lock was identified.The complaint condition is unconfirmed.While no definitive root cause could be determined for the fallen off cam lock, it is possible that the device encountered unintended forces and/or rough handling.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: RADIOLUCENT RECON AIMING ARM FOR EXPERT LFN
• 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: 8945814
• MDR Text Key: 160440786
• Report Number: 2939274-2019-60208
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982069009
• UDI-Public: (01)10886982069009
• Combination Product (y/n): N
• PMA/PMN Number: K040336
• 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: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.010.482
• Device Catalogue Number: 03.010.482
• Device Lot Number: T993311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Date Manufacturer Received: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - NAILS
• Patient Outcome(s): Required Intervention