MAUDE Adverse Event Report: SYNTHES SELZACH 9MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/380MM-STERILE ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.013.356S

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4). Device is not expected to be returned for manufacturer review/investigation. (b)(6). Device history records review was completed for sterilized part #04. 013. 356s, lot # 9546014. Manufacturing location: (b)(4), manufacturing date: jun 30, 2015, expiry date: jun 01, 2025. No non conformance reports were generated during production. Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. Device history records review was completed for non - sterilized part #04. 013. 356, lot # 7814889. Manufacturing location: (b)(4), manufacturing date: may 26, 2015. Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 (b)(4) reports an event in (b)(6) as follow: it was reported that a patient underwent femoral nailing on (b)(6) 2015. On (b)(6) 2016 the patient reported in orthopedic consultation with an x-ray of his femur. The x-ray showed a distal fracture of the nail over the locking screws and a breakage of the two (2) locking screws. The patient, who developed pseudoarthrosis not attributable directly to the rupture of the nail, will have to receive a new osteosynthesis with screwed plate. The impossibility of the extraction of the distal part of the nail will generate an increase in the operating time as well as mechanical mounting plates and screws less satisfactory. The presence of the distal part of the non-extractable nail will not allow the optimum screwing of the plates, resulting in a potential risk of plaque rupture and/or risk of disassembly of the plates. A revision surgery was planned on (b)(6) 2016. No information about patient condition and outcome available. This report is for one (1) sterile femoral nail. This is report 1 of 3 for com-(b)(4).

Manufacturer Narrative

Patient height reported as (b)(6). The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. 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

Device was used for treatment, not diagnosis. A product investigation was performed. The following were received with the complaint category of ¿broken: postoperatively. ¿ one (1) 9mm titanium cannulated retrograde/antegrade femoral nail (part 04. 013. 356s / lot 9546014 and two (2) 5. 0mm titanium locking screws (part 04. 005. 542s / lot 3108385 and part 04. 005. 538s / lot 8634448). Our investigation has shown that the complaint condition is confirmed as all three implants were received in a broken condition. In each case the portion distal to the break was not received. A device history record (dhr) review, manufacturing evaluation, drawing review, complaint history review, and risk assessment review were performed as part of this investigation. Unfortunately we are not able to determine the exact cause of this occurrence as no detailed clinical information is provided and not all involved parts were available. We have forwarded the received devices to the responsible manufacturing site for further evaluation with the following results: all dimensions which are relevant for this complaint condition, were measured, and were found according to our specifications. The returned parts were determined to be suitable for their intended use when employed and maintained as recommended and the risk assessment was found to adequately address the complaint condition. The conditions are consistent with fatigue failure. However, a root cause could not be definitively determined due to the unknown circumstances between implant on (b)(6) 2015 and (b)(6) 2016 when it was reported that the patient presented in orthopedic consultation with an x-ray showing a distal fracture of the nail over the locking screws and a breakage of the locking screws. Finally we conclude that the cause of failure is not due to any manufacturing non-conformances. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 9MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/380MM-STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6144455
• MDR Text Key: 61437257
• Report Number: 3000270450-2016-10285
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033618
• 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: 11/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 04.013.356S
• Device Lot Number: 9546014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2015
• 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: 12/05/2016 Patient Sequence Number: 1