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

Model Number 03.168.013

Device Problem Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/10/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: (b)(6).The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 an unknown date, the tip of the protection sleeve for femoral neck system (fns) insertion instruments was bent when the tray was opened before the surgery.This report is for 1 protection sleeve for fns insertion instruments.This is report 1 of 1 for (b)(4).

Event Description

Updated event description: it was reported that on (b)(6) 2020, the distal tip of the protection sleeve for fns insertion instruments was bent when the tray was opened before the surgery.This complaint involves one (1) device.

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: b3: updated event date b5: updated event description h3, h6: a product investigation was conducted: investigation flow: damage visual inspection: the protection sleeve for fns insertion instruments (part # 03.168.013 / lot # 180242-301) was received at us cq.The distal tip of the device was deformed/bent inward.No additional defects were observed on the complaint device.Device failure/defect was identified.Document/specification review: no design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the distal tip of the device was deformed inward.No definitive root cause could be determined based on the provided information.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.Device history lot part: 03.168.013 lot: 180242-301 manufacturing site: selzach supplier: leitner ag release to warehouse date: december 07, 2018 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's 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: PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS
• 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: 10795388
• MDR Text Key: 215091990
• Report Number: 2939274-2020-04985
• Device Sequence Number: 1
• Product Code: GEA
• UDI-Device Identifier: 10886982274441
• UDI-Public: 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: 10/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 180242-301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Initial Date Manufacturer Received: 10/10/2020
• Initial Date FDA Received: 11/05/2020
• Supplement Dates Manufacturer Received: 11/16/2020
• Supplement Dates FDA Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR