MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM VA-LCKNG SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 8MM; SCREW, FIXATION, BONE

Model Number 02.130.208

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Code Available (3191)

Event Date 03/16/2018

Event Type  Injury  

Manufacturer Narrative

Patient¿s weight is unknown.Additional device product code: hrs.Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 two (2) locking screws would not lock into an unknown plate during a hand fracture repair procedure on (b)(6) 2018.The surgeon was manually placing screws through the screw hole of the plate when the two screws malfunctioned.The procedure was completed without incident using two cortex screws.No patient harm was reported.There was a 45 second surgical delay related to switching the screws.The patient outcome was reported stable.Procedure was completed successfully.This is report 2 of 3 for complaint (b)(4).

Manufacturer Narrative

Product development investigation was completed.The screw was received at customer quality (cq) with minor wear, but no damage that would inhibit function was observed.The stardrive screw head recess shows wear consistent with interaction with a screwdriver during attempted screw insertion.The reported complaint condition of not locking to the plate was not able to be confirmed or replicated at customer quality (cq) via functional test because the plate involved in the event was not returned for investigation.A review of the device history records was unable to be performed since the lot number was unknown.A material check was not performed at cq as there is no indication that the material would have contributed to this complaint.Tabulated product drawing for the family of 1.5mm variable angle screws was reviewed during this investigation.The returned screw is an implant in the variable angle locking hand system indicated for fragment specific fracture fixation of the hand.The major shaft thread diameter measured ø1.42mm at cq (ca592) which is within specification of max ø1.55mm per drawing.The proximal major head thread diameter measured ø2.13mm at cq (ca592).However, this dimension is a reference dimension and could not be compared to a specification.Post manufacturing thread wear consistent with attempted locking to a plate has prevented any further relevant accurate dimensional analysis.Definite root cause could not be determined for this complaint.It is possible that the returned va screw was attempted to be inserted outside of the 30-degree cone required by design as there is no mention of using the variable angle drill guide during the event.No product design issues or manufacturing discrepancies were identified during this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: 1.5MM VA-LCKNG SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 8MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7421354
• MDR Text Key: 105147200
• Report Number: 2939274-2018-51578
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886982044624
• UDI-Public: (01)10886982044624(10)LOTNUMBERUNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.130.208
• Device Catalogue Number: 02.130.208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR