MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM LCP STRAIGHT WRIST PLATE 170MM; PLATE, FIXATION, BONE

Model Number	SD242.003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2021, a patient underwent a hardware removal for wrist fusion due to non-union.The procedure was completed successfully.Patient outcome is reported as soft tissue repair.This report is for one (1) 2.4mm lcp straight wrist plate 170mm.This is report 1 of 6 for complaint (b)(4).
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/ investigation.Investigation: the complaint device was not received for investigation.An investigation was performed based on the images provided.The images were reviewed, and the complaint condition cannot be confirmed.There are no visible defects or damage to the device.A definitive assignable root cause could not be determined based on the provided information.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/ specification review were not completed.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.A device history record (dhr) review was conducted: part number: sd242.003-us, lot number: 13l7194, part manufacture date: 05-sep-2019, manufacturing location: (b)(4), part expiration date: n/a, nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 2.4mm lcp straight wrist plate 170mm product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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 LCP STRAIGHT WRIST PLATE 170MM
• 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: 12636349
• Report Number: 2939274-2021-06116
• Device Sequence Number: 3292604
• Product Code: HRS
• UDI-Device Identifier: 10886982003638
• UDI-Public: (01)10886982003638
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K040588
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2021

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: SD242.003
• Device Catalogue Number: SD242.003
• Device Lot Number: 13L7194
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 10/14/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: 2.4 MM LOCKING; UNK - SCREWS: 2.4 MM LOCKING; UNK - SCREWS: 2.7 MM CORTEX; UNK - SCREWS: 2.7 MM LOCKING; UNK - SCREWS: 2.7 MM LOCKING
• Outcome Attributed to Adverse Event: Required Intervention