MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM VA LOCKING SCREW STARDRIVE 16MM; SCREW, FIXATION, BONE

Model Number	02.210.116
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
It was reported that on an (b)(6) 2021 the 2.4mm variable locking compression plate was not able to lock into a screw in the left-most distal ulnar column screw.A total of three (3) locking screws and one (1) plate were tried.The procedure was successfully completed with a thirty (30) minute surgical delay.The patient's status is unknown.This report is for one (1) 2.4mm va locking screw stardrive 16mm.This is report 4 of 4 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: investigation summary visual inspection: the 2.4mm va locking screw sddrive 16mm (p/n: 02.210.116, lot number: unk) was received at us cq.Visual inspection of the complaint device showed the head threads of the screw were stripped.Device failure/defect identified? yes.Functional test: a functional assessment was performed on the complaint device with the returned mating plate.The screw was unable to thread into any of the holes on the plate, likely due to the head thread damage.The complaint was able to be replicated.Dimensional inspection: a dimensional inspection was not performed due to post-manufacturing damage.Document/specification review: no design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the head threads were stripped and the complaint device could not assemble with the mating plate.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.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 the lot number is unknown, therefore no mre can be performed.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.Corrected data: h3, h6.

• Brand Name: 2.4MM VA LOCKING SCREW STARDRIVE 16MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11497399
• Report Number: 2939274-2021-01333
• Device Sequence Number: 19543864
• Product Code: HWC
• UDI-Device Identifier: 10886982052933
• UDI-Public: 10886982052933
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K071184
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2021

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
• Operator of Device: Health Professional
• Device Model Number: 02.210.116
• Device Catalogue Number: 02.210.116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 03/28/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 04/07/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.4MM VA LOCKING SCREW STARDRIVE 16MM; 2.4MM VA LOCKING SCREW STARDRIVE 16MM; 2.4MM VA-LCP 2-CLN VLR DSTL RAD PL 6H HD/3H SFT/RT