MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC NECK FIX BOLT L90 TAN; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.168.290S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Pma/510k #: device is not distributed in the united states, but is similar to device marketed in the usa.(b)(4).Device evaluated by mfr, manufacture date: investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventive 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.A review of the device history record: part: 04.168.290 (60123908), lot: 2l78776, manufacturing site: (b)(4), release to warehouse date: 09.Jan.2019.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.
Event or Problem Description
It was reported that on (b)(6) 2019, the patient underwent a hardware removal due to infection and implant cut through the femoral head.Initially, the patient was implanted with femoral neck system about 3-6 months ago to treat a subcapital femoral neck fracture.As per the surgeon, the antirotation screw and barrel length measured out to be the same size as recommended in the surgical technique.The plate also had two (2) unknown unicortical locking screws that remained intact.Patient outcome and surgery delay were unknown.This complaint involves four (4) devices.This report is for one (1) neck fix bolt l90 tan.This report is 2 of 4 for (b)(4).

• Brand Name: NECK FIX BOLT L90 TAN
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8796236
• Report Number: 2939274-2019-59224
• Device Sequence Number: 1668804
• Product Code: HSB
• UDI-Device Identifier: 10886982274748
• UDI-Public: (01)10886982274748
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/19/2019

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: 04.168.290S
• Device Catalogue Number: 04.168.290
• Device Lot Number: 2L78776
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 07/16/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention