MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HANDLE FOR 90 SCREWDRIVER; SCREWDRIVERS

Model Number	03.505.004
Medical Device Problem Codes	Device Slipped (1584); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is jnj representative.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 or Problem Description
It was reported that on an unknown date, during assembly in sterilization processing department (spd) to check for good operation, the 90-degree screwdriver shaft and 90-degree screwdriver handle were slipping and will not advance the screw.The 90-degree screwdriver t-handle was broken and two little metals pieces at end one is missing causing the device to malfunction.There is no patient involvement.This complaint involves five (5) devices.This report is for (1) handle for 90° screwdriver.This is report 5 of 5 for (b)(4).
Additional 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.H3, h4, h6: part: 03.505.004, lot: 8154010, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 07.Sept.2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the handle for 90° screwdriver (p/n: 03.505.004 & lot number: 8154010) was received at us customer quality (cq) in disassembled condition.The visual inspection of the compliant device showed that the threads on the distal end mating feature of the device were stripped.No other damages were observed on the device except for minimal wear which would not contribute to the complaint condition.Functional test: the complete functional test cannot be performed as all the mating devices were not returned.The screwdriver handle (complaint device) was not able to be completely assembled with the mating device (screwdriver shaft complete; part code: 03.505.003 & lot no: 8176222) as the distal threads on the complaint device were stripped.The assembly of complaint device and mating device was incomplete and loose due to the damaged distal threads on the complaint device.Can complaint be replicated with the returned device(s): unable to perform.Dimensional inspection: the dimensional inspection was not performed due to the post-manufacturing damage document/specification review: current and manufactured were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.The alleged functional issue may be caused due to the damaged distal threads.Investigation conclusion: the overall complaint condition was confirmed for the received device as the threads on the distal end mating feature were stripped, the alleged functional issue may be occurred due to the stripped threads on the complaint device.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: HANDLE FOR 90 SCREWDRIVER
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10897328
• Report Number: 2939274-2020-05301
• Device Sequence Number: 1462512
• Product Code: HXX
• UDI-Device Identifier: 10887587013305
• UDI-Public: (01)10887587013305
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082649
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2020

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
• Operator of Device: Health Professional
• Device Model Number: 03.505.004
• Device Catalogue Number: 03.505.004
• Device Lot Number: 8154010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 12/21/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 90 DEGREE SCREWDRIVER T-HANDLE; SHAFT FOR 90° SCREWDRIVER