MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH PFNA Ø9 130° L240 TAN ROD, FIXATION, INTRAMEDULLARY

Catalog Number 472.401S

Device Problem Bent (1059)

Patient Problems Bone Fracture(s) (1870); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient¿s identifier, date of birth/age and weight are unknown. Date of event is unknown. Implanted in 2008; exact date is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Device is not distributed in the united states, but is similar to device marketed in the usa. (b)(4). The nail was bent requiring revision surgery. 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

Device report from synthes europe reports an event in (b)(6) as follows: it was reported the patient was implanted with a less invasive stabilization system (liss) and a proximal femoral nail anti-rotation (pfna) after a motorcycle accident in 2008, due to a complex multiple supply cut of the right thigh. The patient was free of symptoms. Recently the patient had a further accident where he had a collision with a tree trunk. The patient suffered a break to the thigh between the liss and pfna. An implant removal with new nailing was planned. During surgery, they were not able to remove the blade. The surgery was finished, and an additional surgery with additional instruments was successfully completed on (b)(6) 2017. After the removal, it became apparent that the pfna nail was bent by the new accident. This is evident in hindsight or on the x-ray screen. This also explains why the blade had jammed in the nail and so caused significant difficulties during hardware removal. This report captures the postoperative bent nail. The event of postoperative jammed blade during hardware removal procedure has been captured under linked complaint (b)(4). Concomitant devices reported: pfna blade (part # 04. 027. 017s, lot # 2618178, quantity 1); liss plate (part # unknown, lot # unknown, quantity 1); unknown screws (part # unknown, lot # unknown, quantity unknown). This report is for one (1) pfna nail. This is report 1 of 1 for complaint (b)(4).

Event Description

Further it was reported that during the pfna nail removal procedure re-osteosynthesis using unreamed femoral nail (ufn) was performed on (b)(6) 2017.

Manufacturer Narrative

A device history record (dhr) review was performed for part number: 472. 401s, synthes lot number: 2519028: release to warehouse date: (b)(6) 2009, expiry date: 01. Aug. 2019, manufacturing site: (b)(4). No non-conformance reports (ncrs) were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that 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.

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. 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

Further it was reported that finally, the blade was removed using a hook wire, which is inserted through the femoral neck screw and medially over the blade tip. The inspection of the casing suggests that the oval casing was jammed in the nail, which made removal so difficult. The nail itself can now be removed effortlessly with the extraction instrument. The former bed of the pfna is also chosen as the entry point for the ufn, so as not to further weaken the proximal femur through a new access via the piriform fossa. A nail with a length of 420 mm and a thickness of 11 mm is now inserted with the insertion guide. However, it becomes stuck on the distal screw, so that it is not driven in further in order not to cause any separation of the distal femur. For this reason, a nail with a length of 380 mm is driven in.

• Brand Name: PFNA Ø9 130° L240 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7259174
• Report Number: 8030965-2018-50988
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819292864
• UDI-Public: (01)07611819292864(17)190801(10)2519028
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/01/2019
• Device Catalogue Number: 472.401S
• Device Lot Number: 2519028
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Outcome(s): Required Intervention