MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 9MM/125 DEG TI CANN TFNA 320MM/LEFT - STERILE ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.037.923S

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 the patient as implanted with trochanteric fixation nail-advanced (tfna) system on (b)(6) 2020. On (b)(6) 2020 the surgeon informed of cut-through. After confirmation of cut-through, the patient was weaned. On (b)(6) 2020, reoperation was performed to remove the tfna and fix the bone again by using another nail system. Per surgeon the reason of the cut-through is what there are poor repositioning, the placement position of the blade was toward the front and didn¿t allow the blade sliding. No further information is available. Concomitant devices: titanium locking screw (part# 04. 005. 522s, lot# 2l52816, quantity 1). Titanium locking screw (part# 04. 005. 524s, lot# 27p1280, quantity 1). Proximal femoral nailing system (tfna) end cap (part# 04. 038. 000s, lot# 5l91318, quantity 1). Tfna nail (part# 04. 037. 923s, lot# 13l0148, quantity 1). This report is for one (1) 9mm/125 deg ti cann tfna 320mm/left - sterile. This is report 2 of 2 for complaint (b)(4).

• Brand Name: 9MM/125 DEG TI CANN TFNA 320MM/LEFT - STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 10393541
• MDR Text Key: 202537857
• Report Number: 8030965-2020-05872
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131548
• 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: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 04.037.923S
• Device Lot Number: 13L0148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2019
• 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: 08/11/2020 Patient Sequence Number: 1