MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM NARROW LCP® PLATE 7 HOLES/134MM; PLATE, FIXATION, BONE

Model Number	224.571
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
Additional Manufacturer Narrative
Date of postoperative non-union development is unknown.Additional device codes: hwc, ktt.Date of original implant reported as few months ago; exact date is not known.Complainant part is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was conducted: part number: 224.571; lot number: h266040.Part manufacture date: 09-jan-2017.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 4.5mm narrow lcp plate 7 holes/134mm 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.Product was not returned.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) 2018, the patient underwent a revision surgery due to a nonunion of midshaft humerus and delayed healing.The surgeon removed one (1) 7 holes narrow locking compression plate (lcp) and seven (7) 4.5mm cortex screws.The patient was revised with one (1) 9 holes narrow locking compression plate (lcp) with screws.The original surgery was done few months ago.There was no surgical delay reported.Procedure outcome was successful.This report is for one (1) 4.5mm narrow lcp plate 7 holes.This is report 1 of 2 for complaint (b)(4).

• Brand Name: 4.5MM NARROW LCP® PLATE 7 HOLES/134MM
• 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: 7929625
• Report Number: 2939274-2018-54108
• Device Sequence Number: 16622844
• Product Code: HRS
• UDI-Device Identifier: 10886982158482
• UDI-Public: (01)10886982158482
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K082807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2018

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: 224.571
• Device Catalogue Number: 224.571
• Device Lot Number: H266040
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 10/03/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Weight: 120