MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM VA LOCKING SCREW STARDRIVE 8MM; SCREW, FIXATION, BONE

Catalog Number 02.210.108

Device Problem Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Date of infection and device migration is not known.This report is for two (2) unknown cortical screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a hardware removal and revision surgery was performed on (b)(6) 2018.The initial surgery was performed on (b)(6) 2018 for an open reduction and internal fixation of the distal radius.The hardware removal was due to two (2) 2.7mm proximal cortical screws backing out of the bone.During the surgery there was a lot of fluid in the wound indicating a possible infection.Five cultures were taken to see if an infection is present but results are not yet available.The hardware that was removed was one (1) 2.4mm variable angle locking compression plate (va-lcp) 2 column volar distal radius plate, five (5) 1.8mm buttress screws, one (1) 2.4mm cortical locking screw, and two (2) 2.7mm cortical screws.All parts were intact with no malfunctions.Patient was revised to a dorsal spanning plate and six (6) 2.7mm locking screws.There were no surgical delays, x-rays are not available, surgery was completed successfully and patient outcome was stable.This is report 4 of 4 for (b)(4).

Manufacturer Narrative

Additional product code: hrs.Without a lot number the device history records review could not be completed.Subject device has been received and is currently in the evaluation process.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

This report is for one (1) 2.4mm va locking screw.This is report 4 of 9 for (b)(4).

Manufacturer Narrative

Customer quality conducted an investigation of the returned device.Device condition: the screw was received intact with surface and thread wear consistent with implant and explant.The device was functionally tested with the returned mating plate and found to function as intended.No defects were identified.Based on the provided information no determination regarding the reported infection can be concluded.Thus, as no issue was identified, the complaint condition for this device could not be confirmed and could not be replicated.Lot number review: a dhr review could not be performed as the lot number is unknown.A material check was not performed at cq as there is no indication that material would have contributed to this complaint of infection.Drawing review: the following drawing was reviewed; 2.4mm variable angle locking screw: the device was identified as part number 02.210.108 based on the stardrive recess, purple sputter coat, fluted tip and the following dimensions.The overall length of the device measured 8.43 which is within the specification of 8mm +0.7/-0.The outer head diameter measured 3.36mm which is within the specification of 3.35mm with a head profile tolerance of 0.05mm.The major thread diameter measured 2.32mm which is within the specification of 2.40m max.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Conclusion: based on the provided information no determination regarding the reported infection can be concluded.Thus, as no issue was identified, the complaint condition for this device could not be confirmed.A device history record (dhr) review, device inspection, and drawing review were performed as part of this investigation.No defects were identified with the returned device and no product design issues or discrepancies were observed that may have contributed to the complaint condition.No malfunctions were observed during the course of this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Corrected data: initial medwatch mwr-(b)(4) indicated information was correction.Information was additional narrative, not a correction.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.Pma: 510k.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: 2.4MM VA LOCKING SCREW STARDRIVE 8MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7290560
• MDR Text Key: 100755419
• Report Number: 2939274-2018-50745
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: K103243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.210.108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2018
• Date Manufacturer Received: 04/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 61