MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DRIVING CAP/THREADED; MISC ORTHO SURGICAL INSTR

Model Number 03.010.523

Device Problem Break (1069)

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

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.Reporter is a j&j representative.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 an unknown date, (3) driving caps were located in sterile processing all broken.Sterile processing said they broke trying to disassemble the stoke cap from the unknown insertion handle.There was no procedure and patient involvement.This complaint involves (4) devices.This report is for (1) driving cap/threaded.This report is 1 of 4 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.: d4.Expiration date and lot.D9.Date device returned to manufacturer.H4.Device manufacture date.H6 - codes updated to imdrf codes.Visual inspection: the driving cap/threaded was returned and received at jrz pal.After physical review of the device, it was observed that device is broken from the threaded tip.Broken fragment was not received.Rest of the device shows scratches/normal wear consistent with the device use which would not contribute to the complaint condition.No other issues were observed with the complaint device.Dimensional inspection: complaint relevant dimensional analysis cannot be performed due to post manufacturing damage.Document/specification review: no design issues or discrepancies were identified.Conclusion: the complaint condition was confirmed for the driving cap/threaded.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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 - a manufacturing record evaluation was performed for the finished article lot 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: DRIVING CAP/THREADED
• Type of Device: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13120452
• MDR Text Key: 284701601
• Report Number: 2939274-2021-07306
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886982069351
• UDI-Public: (01)10886982069351
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• 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: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.010.523
• Device Catalogue Number: 03.010.523
• Device Lot Number: L814075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2019
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DRIVING CAP/THREADED; DRIVING CAP/THREADED; UNK - NAIL INSERTION HANDLES