MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TFNA 200MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.037.243S

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that the patient underwent for tfna removed and total hip replacement surgery due to cut out.The device was implanted two years ago.It was unknown if the removal and replacement surgery completed successfully.There were patient consequences are reported.Concomitant device reported: unk - end caps: tfna: (part# unknown; lot# unknown; quality:1).Unk - screws: nail distal locking: (part# unknown; lot# unknown; quality: 1).This complaint involves two (2) devices.This report is for (1)12mm/130 deg ti cann tfna 200mm - sterile.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/ investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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.Device history lot: part #: 04.037.243s, synthes lot #: h445971, supplier lot #: n/a, released to warehouse: 03nov2017, expiration date: 01oct2027, manufactured by: (b)(4).Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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: 12MM/130 DEG TI CANN TFNA 200MM - STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13122560
• MDR Text Key: 286532803
• Report Number: 8030965-2021-10591
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819651234
• UDI-Public: (01)07611819651234
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.243S
• Device Lot Number: H445971
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: TFNA HELICAL BLADE PERF L110 TAN; UNK - END CAPS: TFNA; UNK - SCREWS: NAIL DISTAL LOCKING
• Patient Outcome(s): Required Intervention