MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM LCP(TM) PLATE 7 HOLES/67MM; PLATE, FIXATION ,BONE

Model Number	249.683
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Date of Event	09/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Investigation flow: damage.Visual inspection: the 2.7mm lcp(tm) plate 7 holes/67mm was received at us cq.Upon visual inspection at cq, it is observed that the plate was bent.The rest of the surface of the device shows normal wear which would not contribute to the complaint condition.Thus, the complaint is confirmed.Device failure/ defect found? yes.Dimensional inspection: dimensional inspection of the received device was performed at cq.The width of the plate was intended to be measuring from 7.3mm to 7.7mm and it was measured to 7.42mm which is within specifications.The thickness of the plate near to the bent location was intended to be measuring from 2.55mm to 2.75mm and it was measured to be 2.68mm which is within specification.Documentation/ specification review: no design issues or discrepancies were found during this investigation.Complaint confirmed? yes.Investigation conclusion: visual inspection, dimensional inspection, and document specification review of the received device was performed at cq.The complaint can be confirmed as the device was found to be bent.A definitive root cause could not be determined for the reported problem, but the device might have encountered unintended forces causing it to bend.During the investigation no unidentified product design/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.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 2.7mm locking compression plate (lcp) 7 holes/67mm plate that was used to repair a radius fracture was bent.The patient was lifting weights and as he went to lower the 95-pound barbell the plate bent and refractured his radius.The plate was removed, and it replaced by a larger one.It is unknown if there was a surgical delay.The surgery was successful and patient outcome is unknown.This report is for one (1) 2.7mm lcp(tm) plate 7 holes/67mm.This is report 1 of 1 for (b)(4).

• Brand Name: 2.7MM LCP(TM) PLATE 7 HOLES/67MM
• 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: 9145615
• Report Number: 2939274-2019-61115
• Device Sequence Number: 2622616
• Product Code: HRS
• UDI-Device Identifier: 10886982171283
• UDI-Public: (01)10886982171283
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K063049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/06/2019

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: 249.683
• Device Catalogue Number: 249.683
• Device Lot Number: 9576544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 10/02/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 14 YR
• Patient Weight: 61