MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11.0MM TI HELICAL BLADE 100MM; ROD,FIXATION,INTRAMEDULLARY

Model Number	456.305
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
Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).Investigation summar: 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 history: part number: 456.305.Lot number: 4826271.Part manufacture date: n/a.Manufacturing location: n/a.Part expiration date: n/a.Nonconformance noted: n/a.Dhr record review: a review of the device history record could not be performed as the product was not returned and the lot number provided does not match the part number.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/revision of 1 titanium helical blade, 1 titanium cannulated trochanteric fixation nail, 1 end cap and 2 locking screws for total hip replacement due to non-union.This is report 1 of 5 for (b)(4).

• Brand Name: 11.0MM TI HELICAL BLADE 100MM
• 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: 10051205
• Report Number: 2939274-2020-02320
• Device Sequence Number: 3017049
• Product Code: HSB
• UDI-Device Identifier: 10886982226716
• UDI-Public: (01)10886982226716
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K011857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/30/2020

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: 456.305
• Device Catalogue Number: 456.305
• Device Lot Number: 4826271
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 05/13/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR