MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 6H HD/5H SHAFT/RIGHT; PLATE, FIXATION, BONE

Model Number	02.111.650
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: initial reporter is a synthes sales consultant.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 (b)(6) 2019, the patient underwent an open reduction internal fixation (orif) of the distal radius because the 2.4 mm variable angle locking compression plate (lcp) two-column volar distal radius plate, right broke and the fracture was not healed.It is unknown if there was a surgical delay.Procedure outcome is unknown.Patient status is unknown.Concomitant device reported: screw (part/lot unknown, quantity unknown).This report is for a 2.4 mm variable angle locking compression plate (lcp) two-column volar distal radius plate, right.This is report 1 of 1 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.The picture of the 2.4 mm variable angle lcp two-column volar distal radius plate, right (part # 02.111.650, lot # unknown) was received showing the plate broken into 2 pieces.This is consistent with the reported complaint condition, thus confirming the complaint.Conclusion: the complaint condition is confirmed as the picture of the 2.4 mm variable angle lcp two-column volar distal radius plate (part # 02.111.650, lot # unknown) was received showing the plate broken into 2 pieces.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 6H HD/5H SHAFT/RIGHT
• 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: 8440720
• Report Number: 2939274-2019-57075
• Device Sequence Number: 16231903
• Product Code: HRS
• UDI-Device Identifier: 10886982032072
• UDI-Public: (01)10886982032072
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K083694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.111.650
• Device Catalogue Number: 02.111.650
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 03/21/2019
• Supplement Report FDA Received Date: 04/12/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention