MAUDE Adverse Event Report: SYNTHES BETTLACH PFNA-II BLADE L100 TAN ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.027.055S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis. Additional device product code is hwc. (b)(4). Due to the intra-operative events, the device was not successfully implanted. An alternate device was used to complete procedural step. As such, implant/explant dates are not applicable. (b)(6). Device is not distributed in the united states, but is similar to device marketed in the usa. The subject device has been received and is currently in the evaluation process. A device history record review was performed for the subject device lot number 9804670. Manufacturing location: synthes (b)(4). Date of manufacture: oct 27, 2015. Expiration date: oct 1, 2025. The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. No non-conformances were generated during the production of the subject device. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Synthes europe reported an event in (b)(6) as follows: it was reported that during surgery to treat a trochanteric fracture on (b)(6) 2016, the surgeon was using the impactor in conjunction with the inserter connected with the pfna (proximal femoral nail antirotation) blade. The surgeon reportedly made sure that the blade¿s tip of the fin rotated so and he inserted the blade into the femur. After he completed the insertion, he turned the inserter clockwise to lock the blade; however, he could not completely close the gap between the blade and the inserter. He replaced the blade with a new one and repeated the process. He was able to complete the locking process on the second attempt. The blade and the inserter were connected by the surgeon and a scrub nurse pressing the blade with a wrench and the tip of the fin rotated. There was a surgical delay of ten (10) minutes due to the reported event. There is no available information regarding the patient and surgical outcome. After the procedure, the surgeon tested the device a few more times and the same thing happened and at other times didn¿t. Concomitant devices reported: one unknown nail. This report is 1 of 1 for (b)(4).

Manufacturer Narrative

The manufacturer investigation results are as follows. Upon visual inspection the blade was in used but good condition. A device history record (dhr) review was performed for the affected lot, no abnormalities or deviations were detected, which could lead to the complaint failure. The article was manufactured in october 2015. No ncrs were marked in the dhr during production. Moreover a review of our complaints data base shows, that there are no other complaints for this issue from this article and lot number. During investigation a functional test was performed. The implant passed the functional test and is working as intended. Based on this the complaint is not confirmed. Unfortunately we are not able to determine the exact reason for this occurrence, but we have to assume that during the operation an application error may have taken place. 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.

• Brand Name: PFNA-II BLADE L100 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6127714
• MDR Text Key: 60907396
• Report Number: 9612488-2016-10481
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 04.027.055S
• Device Lot Number: 9695723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2016
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2015
• 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: 11/25/2016 Patient Sequence Number: 1

Treatment

ONE UNKNOWN NAIL