MAUDE Adverse Event Report: SYNTHES BETTLACH PFNA-II BLADE L95 TAN ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.027.054S

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis. Patient¿s initials and weight are not available for reporting. (other number) udi # (b)(4). Complainant part is not expected to be returned. (b)(6). Device is not distributed in the united states. The investigation could not be completed; no conclusion could be drawn, as no product was received. Part number: 04. 027. 054s, synthes lot number: 9659176, release to warehouse date: sep 24, 2015, expiration date: sep 1, 2025, mfg. Site: (b)(4). No ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition. 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) is as follows; it was reported that a revision surgery was performed on b)(6) 2016 due to a cutout of a proximal femoral nail antirotation (pfna) blade. The patient was revised to a bipolar hip arthroplasty (bha). The procedure was completed successfully. The patient is doing well. The patient was initially treated on b)(6) 2016 for femur trochanteric fracture with proximal femoral nail antirotation (pfna) and a pfna-blade. The surgeon judged this as jugular base fracture. He completed the surgery but was concerned about unstable rotation so he relieved the rehabilitation after the surgery. Ten (10) days later, the patient transferred to another hospital. Forty (40) days after the surgery, the blade was cutout so the patient returned to the previous hospital. No information regarding the rehabilitation is available. Concomitant devices reported: proximal femoral nail antirotation (part # 472. 105s, lot # 9705665, quantity # 1). This is report number 1 of 1 for b)(4).

• Brand Name: PFNA-II BLADE L95 TAN
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6141942
• MDR Text Key: 61337569
• Report Number: 9612488-2016-10489
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 04.027.054S
• Device Lot Number: 9659176
• 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: 11/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2015
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 12/02/2016 Patient Sequence Number: 1

Treatment

PROXIMAL FEMORAL NAIL ANTIROTATION (PART # 472.105