MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA HELICAL BLADE 100MM STERILE ROD,FIXATION,INTRAMEDULLARY

Model Number 04.038.300S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

Patient identifier, weight, and ethnicity not available for reporting. Date of event: date of fracture is not known. Date of implant is not known. Complainant part is not expected to be returned for manufacturer review/investigation. A review of the device history records has been requested. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 Description

It was reported that on (b)(6) 2018, patient underwent a removal of a trochanteric fixation nail advanced (tfna) due to a fracture that occurred at a point of a stress riser between the tfna nail and a variable angle (va) condylar plate. The tfna nail was easily removed and replaced with a new, longer tfna nail which extended beyond the plate. An unknown quantity of cables were also placed to augment the construct, as well as an unknown quantity of screws. No fragments were produced. It is not known if surgery was delayed. Patient outcome is not known. This report is for one (1) tfna helical blade 100mm. This is report 2 of 5 for (b)(4).

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. Part: 04. 038. 300s; lot: 9909005; part manufacturing date: october 15, 2015; manufacturing site: elmira; part expiration date: september 30, 2025; nonconformance noted: n/a a review of the device history record revealed no complaint related anomalies. The device history record shows this lot of tfna helical blades was processed through the normal manufacturing and inspection operations with no rework or nonconformances noted. This 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. A review of the raw material device history record(s) determined the raw material lot met all specifications with no issues documented that would contribute to this complaint condition. 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 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: TFNA HELICAL BLADE 100MM STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7782679
• Report Number: 2939274-2018-53327
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982099037
• UDI-Public: (01)10886982099037
• Combination Product (y/n): N
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 04.038.300S
• Device Catalogue Number: 04.038.300S
• Device Lot Number: 9909005
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/17/2018

Is This a Reprocessed and Reused Single-Use Device?

• Patient Age: 86 YR
• Patient Outcome(s): Required Intervention