MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP PLATE 6 HOLES 85MM; PLATE, FIXATION, BONE

Model Number	223.561
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product codes: hwc, ktt.Complainant part is not expected to be returned for manufacturer review/ investigation.(b)(4).A device history record (dhr) review was conducted: part number: 223.561, lot number: h406595, part manufacturing date: 20 july 2017, manufacturing site: (b)(4), part expiration date: n/a, nonconformance noted: n/a.A review of the device history record revealed no complaint related anomalies.The device history record shows lot h406595 of 3.5 mm lcp plates was processed through the normal manufacturing and inspection operations with no rework or nonconformance noted.This 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.A review of the raw material device history record(s) determined the raw material lot h293246 met all specifications with no issues documented that would contribute to this complaint condition.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) 2020, the patient underwent removal of the 3.5mm locking compression plate (lcp) plate along with the two (2) unknown locking screws and two (2) unknown cortex screws due to uncomfortableness in the wrist.The implants were originally implanted on (b)(6) 2019.The plate and four (4) screws were removed successfully.The procedure was successfully completed.Patient was not revised to new devices.Patient outcome is unknown.This report is for one (1) 3.5mm lcp plate 6 holes 85mm.This is report 1 of 5 for (b)(4).

• Brand Name: 3.5MM LCP PLATE 6 HOLES 85MM
• 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: 10434860
• Report Number: 2939274-2020-03709
• Device Sequence Number: 19750064
• Product Code: HRS
• UDI-Device Identifier: 10886982157911
• UDI-Public: (01)10886982157911
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K082807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/27/2020

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: 223.561
• Device Catalogue Number: 223.561
• Device Lot Number: H406595
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 08/20/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 96