MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PROTECTION SLEEVE FOR FNS INSRT INSTS; CANNULA,SURGICAL,GENERAL & PLASTIC SURGERY

Model Number 03.168.013

Device Problem Material Deformation (2976)

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

Event Date 03/25/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; 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 surgeon inserted the drill guide for the 5.0 distal screw of the fns using a mallet.This caused the drill guide to bend due to hitting it with the mallet.He was able to drill through the guide, but the screw was not able to pass through the guide due to the bend.He was able to insert the screw without the guide.The drill guide needs to be replaced.Removed the drill guide.There were no fragments generated.There was no surgical delay.The surgery was completed successfully.No patient consequence.Concomitant device reported: unk - mallet (part# unknown; lot# unknown; quantity: 1).Unk - screw (part# unknown; lot# unknown; quantity: unknown).This complaint involves one (1) device.This report is for (1) protection sleeve for fns insrt.Instus.This report is 1 of 1 (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: a product investigation was conducted.Visual inspection: the protection sleeve for fns insrt insts (p/n: 03.168.013, lot number: 180114-101) was received at us cq.Upon visual inspection, the distal end of the device was deformed and bent.Additionally scratches from field usage were observed all along the device, which do not affect the functionality of the device.Dimensional inspection: diameter of the shaft was measured and found to be conforming per relevant drawing.Document/specification review: the relevant documents were reviewed: no design issues or discrepancies were identified.Investigation conclusion: this complaint could be confirmed for the returned device as the drill guide was bent at the distal end.No definitive root cause could be determined based on the provided information.However, the deformation observed could have potentially been a result of the device experiencing unintended forces from the mallet strikes.No new, unique or different patient harms were identified as a result of this evaluation.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 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.A device history record (dhr) review was conducted: part: 03.168.013.Lot: 180114-101.Manufacturing site: selzach.Supplier: leitner ag.Release to warehouse date: 27.Sep.2018.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: PROTECTION SLEEVE FOR FNS INSRT INSTS
• Type of Device: CANNULA,SURGICAL,GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11703674
• MDR Text Key: 268297031
• Report Number: 2939274-2021-02007
• Device Sequence Number: 1
• Product Code: GEA
• UDI-Device Identifier: 10886982274441
• UDI-Public: (01)10886982274441
• 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
• Report Date: 03/25/2021

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: 03.168.013
• Device Catalogue Number: 03.168.013
• Device Lot Number: 180114-101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Initial Date Manufacturer Received: 03/25/2021
• Initial Date FDA Received: 04/21/2021
• Supplement Dates Manufacturer Received: 04/28/2021
• Supplement Dates FDA Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA; UNK - SCREWS: TRAUMA
• Patient Age: 91 YR