MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 6H HD/2H SHAFT/LEFT; PLATE, FIXATION, BONE

Model Number	02.111.621
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number is unknown.Device has not been reported as explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter email address is unavailable.Reporter is a synthes sales consultant.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 or Problem Description
It was reported that during a distal radius fracture procedure on (b)(6) 2018, the locking screw did not thread into the variable angle (va) locking compression (lcp) distal radius plate.The procedure was completed using a different locking screw.It is unknown if there was a surgical delay.Patient outcome is unknown.This report is for a 2.4mm va-lcp 2-clmn vlr dstl radius pl 6h hd/2h shaft/left.This is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Device history records review was completed for part# 02.111.621, lot# l772062.Manufacturing location: (b)(4), release to warehouse date: feb 26, 2018.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product development investigation was completed.The va lcp plate was received with stripped threads at va6 hole.Additionally, scratches were observed at the elongated lcp combi hole, which would not contribute to the complaint condition.No new malfunctions were observed on the device.Based on the visual inspection, the received condition agreed with the complaint description, therefore the complaint is confirmed.Dimensional analysis was not performed as the returned device was received with post manufacturing damage (stripped threads).Relevant drawing was reviewed during investigation.While no definitive root cause could be determined, it is possible that the device encountered excessive force/torque during insertion that could contribute to the complaint condition of locking screw unable to thread into the va lcp plate.During the investigation, no product design or manufacturing issues or 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 or Problem Description
It was reported that during a distal radius fracture procedure on (b)(6) 2018, the locking screw did not thread into the variable angle (va) locking compression (lcp) distal radius plate.The procedure was completed using a new plate and screw.It is unknown if there was a surgical delay.Patient outcome is unknown.
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.A review of the device history records has been requested.Subject device has been received and is currently in the evaluation process.Device malfunctioned intra-operatively and was not implanted / explanted.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-LCP 2-CLMN VLR DSTL RADIUS PL 6H HD/2H SHAFT/LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7647390
• Report Number: 2939274-2018-52675
• Device Sequence Number: 13491992
• Product Code: HRS
• UDI-Device Identifier: 10886982031976
• UDI-Public: (01)10886982031976
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K083694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2018

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: 02.111.621
• Device Catalogue Number: 02.111.621
• Device Lot Number: L772062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Initial Date Received by Manufacturer: 06/06/2018
• Supplement Date Received by Manufacturer: 06/29/2018; 07/26/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 07/24/2018; 07/31/2018
• Patient Sequence Number: 1
• Patient Age: 43 YR