MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH PFNA BLADE L110 TAN ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.027.017S

Device Problem Mechanical Jam (2983)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Date of implant reported as 2008, exact date is not known. 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

A device history record (dhr) review was performed for part number: 04. 027. 017s, synthes lot number: 2618178: release to warehouse date: 29. Jun. 2010 expiry date: 01. Jun. 2020, 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. Product was not returned. The device history record was researched; no abnormal findings were identified. Manufacturing and inspection records indicated no problems with the lot in question. Based on these findings we conclude that the cause of failure is not due to any manufacturing non-conformance. Based on the information available, 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. The received pictures and x-ray confirm the issue as per event description; the complaint therefore has been determined to be confirmed. 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

Patient id/initials, age/date of birth and weight are unknown. Complainant part is not expected to be returned for manufacturer review/investigation. G5: device is not distributed in the united states, but is similar to device marketed in the usa. 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 (b)(4) 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. Concomitant device: pfna nail (part 472. 401s, lot 2519028, quantity 1). This is report 1 of 1 for (b)(4).

• Brand Name: PFNA BLADE L110 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7219360
• MDR Text Key: 253076837
• Report Number: 8030965-2018-50598
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/01/2020
• Device Catalogue Number: 04.027.017S
• Device Lot Number: 2618178
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 06/29/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 01/25/2018 Patient Sequence Number: 1