MAUDE Adverse Event Report: SYNTHES BETTLACH PFNA BLADE PERF L95 TAN; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.027.034S

Device Problem Mechanical Jam (2983)

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

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient information is not available for reporting.Event date: unknown (b)(4).Device was not implanted/explanted.(b)(6).Device is not distributed in the united states, but is similar to device marketed in the usa.Manufacturing location: (b)(4), manufacturing date: 21.July 2016, expiry date: 01.July 2026.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The blade was received jammed within the impactor.It is impossible to detach both devices from each other.There are marks at the shaft of the blade visible.Furthermore we found hammer marks on the metallic part at the top of the handle.Because of the damage, the complaint relevant dimensions cannot be checked for dimensional accuracy of the valid manufacturing specifications.Unfortunately, due to limited information, a root cause cannot be determined.Due to the wear and tear marks, it can be presumed that the instrument was subjected to excessive force application during use, which finally could cause the jamming of both devices.The technical guide recommends: for impactor- insert the pfna blade to the stop by applying gentle blows with the hammer.Inserting the blade to the stop is important, as the impactor must click into the protection sleeve.Do not use unnecessary force when inserting the pfna blade.For blade - the tip of the pfna blade must rotate freely after attaching it to the impactor.This is essential for the implantation of the pfna blade.Otherwise remove and dispose of the blade.Do not over tighten the connection between the impactor and the pfna blade.No product fault could be detected.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 europe reports an event in (b)(6) as follows: it was reported during a procedure, the blade became stuck on the screwdriver.The screw was still able to be removed and a new one was implanted.No patient harm reported.During the investigation process, it was found that the blade also malfunctioned.Concomitant device reported: impactor (part 03.010.410, lot 9349629, qty 1).This is report 2 of 2 for (b)(4).

• Brand Name: PFNA BLADE PERF L95 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: 6182011
• MDR Text Key: 62685095
• Report Number: 9612488-2016-10515
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.034S
• Device Lot Number: L066996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2016
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 03.010.410