MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM VA LCK SCREW SLF-TAP; SCREW, FIXATION, BONE

Catalog Number 02.211.036

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2018

Event Type  malfunction  

Manufacturer Narrative

Additional patient identifier: (b)(6).Additional product code: hrs.Device malfunctioned intra-operatively and was not implanted / explanted.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

It was reported patient underwent an unknown foot procedure on (b)(6) 2018.During the procedure, surgeon was not able to lock the 2.7mm variable angle (va) locking screw to the 2.4/2.7mm va locking compression plate (lcp) tarsometatarsal (tmt) fusion plate.Another plate and screw was used to complete the procedure.During the same procedure, surgeon used the reamer/irrigator/aspirator (ria) in the femur to obtain a bone graft.Once the graft was obtained and the ria was removed from the femur, it was noted that the tip of the ria drive shaft had broken.Fragments from the broken device were not able to be retrieved and remain in the patient.Surgery was completed successfully with a delay of approximately 30 minutes.Concomitant devices reported: 15.5mm reamer head for ria (352.257s, lot number unknown, quantity 1).This report is for one (1) 2.7mm va locking screw 36mm.This is report 2 of 3 for (b)(4).

Manufacturer Narrative

Investigation flow: device interaction/function.Visual inspection: the va locking screw was received with stripped threads at the head of the screw.The received condition of the device agreed with the complaint description.Functional test: a functional test was able to be performed as the variable angle locking compression plate (va lcp) plate was returned and the complaint condition was replicated with the returned plate.The va lcp plate and the va locking screw were not able to thread with each other as the returned devices visually shown post manufacture damage to the threads.Therefore, the complaint condition is confirmed.Dimensional inspection: dimensional analysis measured the diameter of the screw at 2.62mm (ca 215), which is within specifications of max tolerance of 2.70mm per drawing.The diameter of the head was not able to be measured as it was received stripped.Document/specification review: the device drawings were reviewed: 2.7mm variable angle locking screw/self-tapping, stardrive screw.A review of the device history records was unable to be performed since the lot number was unknown.Conclusion: while no definitive root cause could be determined, it is possible that unintended forces encountered by the device could contribute to the complaint condition.Therefore, the complaint is confirmed.During the investigation, no product design issues or manufacturing discrepancies were observed that may have contributed to the complaint condition.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.

Event Description

It was reported patient underwent an unknown foot procedure on (b)(6) 2018.During the procedure, surgeon was not able to lock the 2.7mm variable angle (va) locking screw to the 2.4/2.7mm va locking compression plate (lcp) tarsometatarsal (tmt) fusion plate.Another plate and screw was used to complete the procedure.During the same procedure, surgeon used the reamer/irrigator/aspirator (ria) in the femur to obtain a bone graft.Once the graft was obtained and the ria was removed from the femur, it was noted that the tip of the ria drive shaft had broken.Fragments from the broken device were not able to be retrieved and remain in the patient.When the ria drive shaft broke off with unretrieved fragments left in the femur, the surgeon decided not to use any of the bone graft already harvested from the patient, as it may have contained fragments from the broken drive shaft.Instead he used allograft (demineralized bone graft) to complete the procedure.The new plate and screw had already been implanted.Surgery was completed successfully with a delay of approximately 30 minutes.Concomitant devices reported: 15.5mm reamer head for ria (352.257s, lot number unknown, quantity 1).

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.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.

• Brand Name: 2.7MM VA LCK SCREW SLF-TAP
• 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: 7635765
• MDR Text Key: 112573191
• Report Number: 2939274-2018-52619
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: K100776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.211.036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Date Manufacturer Received: 07/23/2018
• Patient Sequence Number: 1
• Patient Age: 54 YR