MAUDE Adverse Event Report: SYNTHES BETTLACH PFNA BLADE PERF L100 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.027.035S

Device Problem Sticking (1597)

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

Event Date 12/18/2015

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information not provided by reporter.510k#: device is not distributed in the united states, but is similar to device marketed in the usa.Device is an instrument and is not implanted/explanted.(b)(6).Device history records was conducted.The report indicates that the: manufacturing location: (b)(4), 04.027.035s lot.9632082, manufacturing date: 02 september 2015, expiry date: 01 august 2025, no ncr's were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the 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

Report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that during a pfna nail implantation, the blade is stuck in the ancillary/ impactor.The surgery was extended for a few minutes the time necessary to take another blade.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Additional product codes for this report include hwc.(b)(4).Product investigation summary: article 04.027.035s / pfna blade perf l100 tan / lot number 9632082, article 03.010.410 / impactor f/pfna blade / lot number 2765046.The blade is jammed within the impactor.It is impossible to detach both devices from each other.There are marks of forcible use visible at the shaft of the blade.The blue handle of the impactor came off as the welding connection of handle and shaft broke.Furthermore, strong hammer marks were found on the metallic part at the top of the handle.Due to the damage incurred, the complaint relevant dimensions cannot be checked for dimensional accuracy against the valid manufacturing specifications.Unfortunately, only limited information was provided in the complaint description; therefore, it cannot be confirmed how this event happened.The manufacturing review shows that the production procedure of both devices was according to the specifications and there were no issues that would contribute to this complaint condition.Due to the wear and tear signs, and the age of the impactor, it is likely that this product was often and intensively used.Due to the heavy hammering marks, the instrument was likely subjected to excessive use resulting in rupture of the welding between the stroke cap and the shaft.No product fault could be detected.The device became stuck on the impactor during insertion and was not implanted or explanted.Device 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 BLADE PERF 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5359393
• MDR Text Key: 35608572
• Report Number: 9612488-2016-10017
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.035S
• Device Lot Number: 9632082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/21/2015
• Initial Date FDA Received: 01/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1