MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TFNA FENESTRATED HELICAL BLADE 110MM - STERILE ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.038.410S

Device Problems Migration or Expulsion of Device (1395); Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Device history record review was performed on part number: 04. 038. 410s, lot number: h090430: date of manufacture: 18 may 2016, place of manufacture: (b)(4), part expiration date: 01 may 2026, nonconformance noted: n/a: description of dhr review: a review of the device history record revealed no complaint related anomalies. The device history record shows this lot of tfna fenestrated helical blade 110mm sterile product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted. This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition. A review of the raw material device history record revealed this lot met all specifications with no non-conformance noted. This raw material 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 product investigation was performed on the subject device. The returned tfna titanium helical blade is part of the tfn-advanced proximal femoral nailing system for intramedullary fixation of proximal femoral fractures. The returned tfna titanium helical blade (04. 038. 410s, h090430) was received with superficial indications of having been implanted and removed, but no indication of any damage or inconsistencies which could have contributed to the complaint condition. Although additional details provided by the reporter indicated that the head element had migrated medially through the acetabulum, the complaint condition could not be confirmed and further replication is inapplicable. The returned tfna titanium helical blade (04. 038. 410s, h090430) was manufactured on 18may16 and relevant drawing was reviewed and determined to be suitable for the intended design, application, and dimensional conformity when used and handled as recommended. No mrrs, ncrs, or actions related to the complaint condition were generated during production of the returned part(s). Review of device history record(s) showed that there were no issues during the manufacture of the product(s), which would contribute to the complaint condition. The material, material properties, and hardness of the returned part(s) were determined to be conforming at the time of manufacture and based on review of the associated/available dhr(s) and based on the details of the complaint and investigation of the returned part(s), additional material/hardness testing is not required. During the investigation no unidentified product design issues or discrepancies were observed that may have contributed to the complaint condition. Dimensional check was performed and found to be conforming per relevant drawings. Based on the available information it is not possible to determine a definitive root cause for the complaint condition. The associated technique guide indicates that if the associated nail¿s locking mechanism is not turned back ½ turn after initial tightening, controlled collapse and compression of the fracture may not occur. Once compression of the fracture is achieved the head element can be statically locked to prevent sliding of the head element through the nail. Head elements are meant to be locked using 6nm of torque, if the associated torque limiting attachment was not used, or it was not properly calibrated, it could have contributed to the complaint condition. A lack of patient compliance could have also contributed to the complaint condition. Previously reported concomitant device 5. 0mm ti locking screw w/t25 stardrive 54mm for im nails (part # 04. 005. 544, lot # unknown, quantity 1) is upon further investigation is no longer considered as concomitant device and is now considered as impacted product. 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 information is not available for reporting. Date of event is unknown. Additional device product code: ktt. Implanted, explanted date: unknown. The subject device has been received and the product evaluation is in progress. No conclusion can be drawn. 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 that a trochanteric fixation nail-advanced (tfna) screw had travelled medially through the acetabulum only being stopped by the mechanism in the neck that allows slide and controls rotation. Concomitant devices reported: 5. 0mm ti locking screw w/t25 stardrive 54mm for im nails (part # 04. 005. 544, lot # unknown, quantity 1). This report is for one (1) tfna fenestrated helical blade 110mm - sterile. This is report 1 of 1 for complaint (b)(4).

• Brand Name: TFNA FENESTRATED HELICAL BLADE 110MM - STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7212204
• MDR Text Key: 277924269
• Report Number: 8030965-2018-50555
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K160167
• 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
• Report Date: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 04.038.410S
• Device Lot Number: H090430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2016
• 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: 01/23/2018 Patient Sequence Number: 1