MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 11MM/125 DEG TI CANN TFNA 170MM - STERILE ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.037.112S

Device Problem Device Difficult to Maintain (3134)

Patient Problems Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). Device evaluated by mfr, manufacture date: the investigation could not be completed; no conclusion could be drawn at the time of filing this report. A review of the device history record has been requested. Device was used for treatment, not diagnosis.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the patient presented to the hospital with hip pain due to fall post - operatively on (b)(6) 2019. Imaging confirmed a medial migration of the proximal lag screw in trochanteric femoral nailing advanced (tfna) nail through the femoral head and into the pelvic region. The patient had significant alcohol and mental health issues and may have been overdoing it regarding his mobilisation post the insertion of the tfna nail. So, there is a possibility that the screw had started to migrate into the pelvis prior to the fall that brought him to the hospital. The patient was originally implanted with tfna system on (b)(6) 2019. A tfna removal was required followed by a hip replacement in which the revision surgery took place on (b)(6) 2019. The procedure was completed successfully and all implants were explanted. The patient was an in-patient until day 15 and it is unclear as to whether the patient was compliant post discharge. There was no general surgical review that was conducted and that there was no intra-abdominal injuries as per surgeon's impression. Also, there was no abnormality discovered (nad) for blood with the patient's urine and stool. The surgeon believes that this occurred as a result of the screw not being locked off correctly at the primary insertion of the tfna nail. There was also no bone trauma and spicules of bone forced into the pelvis when they opened the patient¿s pelvis to remove the screw. The hole on the inner aspect of the pelvis was about 2. 5 cm in diameter with no bone spicules visible. Also, the surgeon checked the nail once it was removed from the femur and found that the ¿grub screw¿ / locking screw was not down at the region of the proximal hole where the lag screw would normally be locked off and therefore believes that it was never locked off sufficiently to begin with. It is unknown if there was a surgical delay. Patient and procedure outcome were unknown. Concomitant device/s reported: locking screw ( part# 04. 005. 528s, lot# 1l76220, quantity 1). This complaint involves two (2) devices. This report is for one (1) 11mm/125 deg ti cann tfna 170mm - sterile. This report is 2 of 2 for (b)(4).

• Brand Name: 11MM/125 DEG TI CANN TFNA 170MM - 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8720270
• MDR Text Key: 148748407
• Report Number: 8030965-2019-65543
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 04.037.112S
• Device Lot Number: H721428
• 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: 08/20/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 08/29/2018
• 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: 06/20/2019 Patient Sequence Number: 1