MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLCS LLC PEDIATRIC LCP HIP PL 5.0/130/9 HOLES; ORTHOPAEDIC FIXATION PLATE, NON-BIOABSORBABLE, STERILE

Model Number	02.108.343
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.The lot number was unknown.Therefore, the expiration date and device manufacture date were unknown.Without a lot number the device history records review could not be completed.(b)(4).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.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.
Event or Problem Description
It was reported on (b)(6) 2022 that a patient had a history of ewing sarcoma of the right femur.There was approximate 20cm bone defect from a non-union after resection of the sarcoma.The broken plate and all screws and approximated 20cm cement spacer were removed.The femur was reamed with a 11mm ria2 head and finished reaming with a 11.5mm standard reamer and also inserted a 10mm ti cann frn/gt 340mm right femoral nail.The nail locked proximally with 2 each recon screws and distally with 2 each 5.0 locking screws.The plate was originally implanted about 6 weeks ago and broke while the patient was transferring to a chair.The procedure and patient outcome were unknown.No additional information was provided.This report is for one (1) pediatric lcp hip pl 5.0/130/9 holes this complaint involves one(1) device.

• Brand Name: PEDIATRIC LCP HIP PL 5.0/130/9 HOLES
• Common Device Name: ORTHOPAEDIC FIXATION PLATE, NON-BIOABSORBABLE, STERILE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLCS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK RARON (CH); kanalstrasse west 30; raron 3942 ; SZ 3942
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14252903
• Report Number: 2939274-2022-01558
• Device Sequence Number: 20087497
• Product Code: HRS
• UDI-Device Identifier: 10886982029997
• UDI-Public: 10886982029997
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K072095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/29/2022

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: 02.108.343
• Device Catalogue Number: 02.108.343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 13 YR
• Patient Sex: Male