MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LOCKING SCREW FOR IM NAIL 5/ 76/ XL25; ROD,FIXATION,INTRAMEDULLARY

Model Number 04.045.076

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/30/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).The device was 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 on (b)(6) 2021, the patient underwent removal surgery due to the locking screw backed out of the distal hole of the rfna after 2 months.The procedure was successfully completed.There were no patient consequences.Concomitant device reported: unk - nails: rafn: (part# unknown; lot# unknown; quality:1).This complaint involves one (1) device.This report is for (1) locking screw for im nail 5/ 76/ xl25.This report is 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: a product investigation was conducted.Visual inspection: the locking screw for im nail 5/ 76/ xl25 (part# 04.045.076, lot# 83p6613 qty# 1) was returned and received at us cq.An x-ray image was also provided.Upon visual inspection of the provided image, the locking screw was observed to have migrated post-operatively.Visual inspection of the returned device however found no issues with the device.Functional test: functional testing of the received test was not performed at cq as the mating device was not returned.Dimensional inspection: following dimensions measured per relevant drawing.Length (l) was measured.Result: pass.Major diameter (c) was measured.Result: pass.Document/specification review: the relevant drawing(s) was reviewed.No design issues or discrepancies were found during this investigation.Investigation conclusion: the complaint is being confirmed for locking screw for im nail 5/ 76/ xl25 (part# 04.045.076, lot# 83p6613 qty# 1) as the screw was observed to have migrated post-operatively from the provided x-ray image.However, the root cause for the reported issue cannot be determined from the available information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based upon these results, 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.H3, h4, h6: a device history record (dhr) review was conducted: part: 04.045.076-us.Lot: 83p6613.Manufacturing site: grenchen.Release to warehouse date: 13 january 2021.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: LOCKING SCREW FOR IM NAIL 5/ 76/ XL25
• 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: 12537337
• MDR Text Key: 273571077
• Report Number: 2939274-2021-05778
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982293015
• UDI-Public: (01)10886982293015
• Combination Product (y/n): N
• PMA/PMN Number: K201346
• 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: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.045.076
• Device Catalogue Number: 04.045.076
• Device Lot Number: 83P6613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Date Manufacturer Received: 10/06/2021
• Patient Sequence Number: 1
• Treatment: UNK - NAILS: RAFN
• Patient Outcome(s): Required Intervention