MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PEDIATRIC LCP HIP PLATE 5.0MM/130/5 HOLES; PLATE,FIXATION,BONE

Model Number	02.108.341
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product codes: hwc and jds.Complainant part is not expected to be returned for manufacturer review/investigation.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.(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.
Event or Problem Description
It was reported that on (b)(6) 2020, the patient underwent removal of one (1) locking compression plate (lcp) pediatric hip plate, three (3) unknown cortex screws and three (3) unknown locking screws due to cyst growth in the proximal femur.It was revised to femoral recon nail.During surgery the reaming rod with ball tip that was open was not peel pack properly the wire became contaminated due to uneven tearing/peel away.A new reaming wire was used.The patient outcome was as planned.Concomitant devices reported: screws: cortex (part number unknown, lot unknown, quantity 3); screws: locking (part number unknown, lot unknown, quantity 3).This product complaint, (b)(4) is related to (b)(4).This (b)(4) captures the post op event in which a removal surgery was done due to cyst growth and (b)(4) captures the intra-op event in which during removal surgery the reaming rod with ball tip that was open was not peel pack properly, the wire became contaminated due to uneven tearing/peel away.This report involves one (1) pediatric lcp hip plate 5.0mm/130°/5 holes.This is report 1 of 7 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h6: a device history record (dhr) review was conducted: part: 02.108.341.Lot: l802447.Manufacturing site: raron.Release to warehouse date: 06.March 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.

• Brand Name: PEDIATRIC LCP HIP PLATE 5.0MM/130/5 HOLES
• 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: 10239352
• Report Number: 2939274-2020-03115
• Device Sequence Number: 19456964
• Product Code: HRS
• UDI-Device Identifier: 10886982029959
• UDI-Public: (01)10886982029959
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K112085
• 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,Followup
• Report Date (Section B): 06/23/2020

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: 02.108.341
• Device Catalogue Number: 02.108.341
• Device Lot Number: L802447
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 08/07/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: CORTEX; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention