MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP EXT MEDL DSTL HUM PL 4H/RT/111MM-LONG; PLATE, FIXATION, BONE

Model Number	02.117.604
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation could not be completed; no conclusion could be drawn, as no product was received.Product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot: part: 02.117.604, lot: 9031164, manufacturing site: (b)(4), release to warehouse date: 23.June 2014.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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) 2020, the patient underwent a hardware removal due to infection.The procedure was successfully completed with no surgical delay.The patient status is unknown.This is report 3 of 6 for (b)(4).This (b)(4) captures the infection postoperatively while this (b)(4) captures the screws that broke during removal intraoperatively.

• Brand Name: 2.7MM/3.5MM VA-LCP EXT MEDL DSTL HUM PL 4H/RT/111MM-LONG
• 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: 10984425
• Report Number: 2939274-2020-05534
• Device Sequence Number: 14526804
• Product Code: HRS
• UDI-Device Identifier: 10886982037008
• UDI-Public: (01)10886982037008
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/16/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 02.117.604
• Device Catalogue Number: 02.117.604
• Device Lot Number: 9031164
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 12/10/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3.5MM LCP HOOK PLATE 3 HOLE; UNK - SCREWS: CORTEX; UNK - SCREWS: LOCKING; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR