MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RADIOLUCENT INSERTION HANDLE FRN; ROD, FIXATION, INTRAMEDULLARY

Model Number 03.033.001

Device Problems Device-Device Incompatibility (2919); Material Integrity Problem (2978)

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

Event Type  malfunction  

Event Description

It was reported that, during a procedure the antegrade screw hole shows damage and does not let drill sleeve trocar through along with a broken driving cap.Procedure was completed successfully without any surgical delay.No patient consequences.This report is for (1) radiolucent insertion handle frn.This is report 1 of 2 for complaint (b)(4).

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j sales representative.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.

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.Part: 03.033.001 lot: l971715 manufacturing site: hägendorf release to warehouse date: november 15, 2018 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the radiolucent insertion handle frn (product code: 03.033.001 lot #: l971715) was received at jrz pal for investigation.The visual inspection of the received device indicated that it shows scratches and nick marks through its surface.No functional insertion test could be performed.No other issues were identified with the device.Device failure/defect identified? yes dimensional inspection: dimension specification: insertion hole diameter measured dimension: insertion hole diameter: conforming device used ¿ digimatic caliper document/specification review: current and manufactured revisoins no design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: the overall complaint was confirmed for radiolucent insertion handle frn (product code: 03.033.001 lot #: l971715).No definitive root cause could be determined based on the provided 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 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 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 INSERTION HANDLE FRN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13088058
• MDR Text Key: 283680579
• Report Number: 2939274-2021-07231
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982271051
• UDI-Public: (01)10886982271051
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.033.001
• Device Catalogue Number: 03.033.001
• Device Lot Number: L971715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DRIVING CAP/THREADED