MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TFNA HELICAL BLADE PERF L90 TAN ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.038.390S

Device Problems Device Damaged by Another Device (2915); Device-Device Incompatibility (2919); Migration (4003)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown nail head elem-tfna hel/unknown lot. Part and lot number are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. The investigation could not be completed; no conclusion could be drawn, as no product was received. (b)(4). The reported event required medical/surgical intervention to preclude permanent damage to a body structure. The blade and distal locking screw will remain coded for migration. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or 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 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 reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, a patient underwent a second surgery to review a trochanteric fixation nail advance (tfna) nail that presented mobility after insertion in the primary surgery where it was cast on (b)(6) 2018. The surgeon alleges that the mobility of the nail was due to the failures presented by the instruments in the surgery. The instruments they carried brought a damaged piece. Still, the surgeon made the decision to put the nail, as he did not realize that the piece was damaged until later. Therefore, the surgeon decided to put the implant. Subsequently, the implant was moved inside the femur, which could be caused by a poor technique at the time of place. Patient and procedure outcome is unknown. This complaint involves three (3) devices. This report is for (1) unk - nail head elements: tfna helical blade. This report is 1 of 3 for (b)(4).

• Brand Name: TFNA HELICAL BLADE PERF L90 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf PA 4436 ; SZ 4436
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8238607
• MDR Text Key: 132767759
• Report Number: 2939274-2019-55785
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: MX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 04.038.390S
• Device Lot Number: H488767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2017
• Is the Device Single Use?: No

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 01/10/2019 Patient Sequence Number: 1