MAUDE Adverse Event Report: SYNTHES ELMIRA TFNA SCREW 75MM - STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.038.075S

Device Problem Unintended Movement (3026)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

Patient weight is unknown.Date of event is unknown (b)(4).(b)(6).Explant date is not applicable since patient was revised to a total hip implant on (b)(6) 2017.Therapy date of concomitant device is unknown.A review of the device history records has been requested.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 a patient was implanted with a left trochanteric femoral nail advanced (tfna) long nail, lag screw, and two 5.0mm distal locking screws in (b)(6) 2017 to treat an unknown fracture.On an unknown date, it was identified that the lag screw had cut out of the femoral head.On (b)(6) 2017, the patient was returned to the operating room where the devices were all removed intact, without surgical delay.The patient was then revised to a total hip implant.Concomitant devices reported: tfna long nail left (part #: 04.037.025, lot #: h290295, qty.1), 5.0mm distal locking screws (part #: 04.005.530, lot #: unknown, qty.2).(b)(4).

Manufacturer Narrative

Device history records review was conducted.The report indicates that the: dhr review request for part #: 04.038.075s / lot #: h119986.Date of manufacture: 02 august 2016.Manufacturing location: (b)(4).Expiration date: 2026-06-30.A review of the device history record revealed no complaint related anomalies.The device history record shows lot h119986 of tfna screws, sterile was processed through the normal manufacturing and inspection operations with no scrap, 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 9932086 met all specifications with no issues documented that would contribute to this complaint condition.Udi: (b)(4).Device 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.

Manufacturer Narrative

Subject device has been received and a pd investigation was completed.Customer quality (cq) engineering investigation: following complaint device was returned under this complaint.Tfna screw 75mm - sterile - p/n 04.038.075s, lot# h119986.A device history review (dhr), device inspection, drawing review and dcrm review were performed as part of this investigation.This complaint can not be confirmed without x-rays or visual evidence of the complaint condition.This complaint cannot be replicated as the conditions inside the patient's body cannot be re-created at the cq location.No new malfunctions were identified as a result of this investigation.Concomitant devices returned: tfna long nail left (part #: 04.037.025, lot #: h290295, qty.1), 5.0mm distal locking screws (part #: 04.005.530, lot #: unknown, qty.2).The nail contains some gouging on the area above the proximal entry point for the lag screw.This was probably caused while removing the nail during revision surgery.No damage was observed to the proximal hole that serves as an entry point for the lag screw.The internal locking device looked intact.Similarly, the distal locking screws show some wear which is inline with the implantation and removal of these implant.Hence, no further investigation was deemed necessary and hence not performed for the returned concomitant devices.Device 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 SCREW 75MM - STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer (Section G): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6976244
• MDR Text Key: 90204290
• Report Number: 3003506883-2017-10248
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.075S
• Device Lot Number: H119986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: PART #: 04.005.530, LOT #: UNKNOWN, QTY. 2; PART #: 04.037.025, LOT #: H290295, QTY. 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR