MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5 LCP X-ARTC DSTL HUM PL 8H/RT 194 LG; PLATE,FIXATION,BONE

Model Number	02.104.008
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Reporter is a j&j sales representative.Investigation summary: 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: apr 26, 2021.A dhr review was not performed for this pi.This lot was manufactured by j&j sales representative.Please re-assign this task to the correct group.Apr 26, 2021 by: (b)(6).Part number: 02.104.008.Lot number: h406346.Part manufacture date: jul 18, 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 3.5mm lcp extra-articular distal humerus pl 8h/rt 194mm long 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.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) 2021, the patient underwent revision surgery due to patients humerus had a nonunion.Removal of the plate and screws was conducted.Surgeon then inserted a bone graft from the patients tibia and applied a large fragment plate.Three of the cortex screws were broken at the head-shaft junction.Additional x-rays for the removal of broken screw shafts.There was a surgical delay of approximately 15 minutes to surgical time.The procedure successfully completed.The patient was revised with a new device.Concomitant devices reported: unknown 3.5mm cortex screws (part# unknown, lot# unknown, quantity 3).This complaint involves 5 devices.This report is for (1) 3.5 lcp x-artc dstl hum pl 8h/rt 194 lg.This report is 1 of 5 (b)(4).

• Brand Name: 3.5 LCP X-ARTC DSTL HUM PL 8H/RT 194 LG
• 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: 11822319
• Report Number: 2939274-2021-02362
• Device Sequence Number: 3610705
• Product Code: HRS
• UDI-Device Identifier: 10886982029027
• UDI-Public: (01)10886982029027
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K031178
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/19/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.104.008
• Device Catalogue Number: 02.104.008
• Device Lot Number: H406346
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention