MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM NARROW LCP PLATE 6 HOLES/116MM; PLATE, FIXATION, BONE

Model Number	224.561
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Impaired Healing (2378); No Code Available (3191)
Date of Event	01/01/2020
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.A device history record (dhr) review was conducted: part number: 224.561, lot number: h769514, part manufacturing date: 09 november 2018, 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 h769514 of 4.5 mm narrow 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 h684573 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 4.5mm narrow locking compression plate (lcp) 6 holes plate and six (6) 4.5mm unknown cortex screw as the surgeon was not pleased with the results of the operation.The surgeon performed de-rotational osteotomy about six (6) weeks ago and the patient was implanted with the locking compression plate (lcp) system.However, deformity correction was not successfully done, and needed correction.So, the surgeon removed the plate and the unknown cortex screws and adjusted the osteotomy and used an unknown femoral recon nail to fixate.There was no allegation against depuy synthes devices.It is unknown if there was a surgical delay.The patient and surgical outcome were unknown.This report is for one (1) 4.5mm narrow lcp® plate 6 holes/ 116mm.This is report 1 of 7 for (b)(4).

• Brand Name: 4.5MM NARROW LCP PLATE 6 HOLES/116MM
• 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: 10432837
• Report Number: 2939274-2020-03690
• Device Sequence Number: 3447224
• Product Code: HRS
• UDI-Device Identifier: 10886982158468
• UDI-Public: (01)10886982158468
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K082807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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: 224.561
• Device Catalogue Number: 224.561
• Device Lot Number: H769514
• 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 Age: 20 YR
• Patient Weight: 57