MAUDE Adverse Event Report: SYNTHES BETTLACH PFNA BLADE PERF L95 TAN; APPLIANCE,FIXATION,NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT

Catalog Number 04.027.034S

Device Problem Fitting Problem (2183)

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

Event Date 04/24/2017

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient id, dob & weight not provided for reporting.Device is not distributed in the united states, but is similar to device marketed in the usa.Other udi (b)(4).Implant and explant dates: device malfunctioned intra-operatively and was not implanted / explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.Initial reporters phone number: (b)(6).Pma 510k# unknown: device history records review was conducted.The report indicates that the 04.027.034s / l330391; please note, this dhr review is for sterilization procedure only: manufacturing location: (b)(4).Manufacturing date: 08.March 2017 expiry date: 01.March 2027.Additional dhr information: dhr review for subcomponent 60039998 with lot number l097939: manufacturing location: (b)(4).Manufacturing date: 26.Oct.2016.Dhr review for subcomponent 60026319 with lot number l322152: manufacturing location: (b)(4).Manufacturing date: 20.Feb.2017.Dhr review for subcomponent 60026321 with lot number l313915: manufacturing location: (b)(4).Manufacturing date: 15.Feb.2017.Dhr review for subcomponent 60026322 with lot number l245011: manufacturing location: (b)(4).Manufacturing date: 10.Feb.2017.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.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 on an event in (b)(6) as follows: it was reported that during centromedullary nailing, it was not possible to lock the proximal femoral antirotate (pfna) blade.The blade had to be removed and replaced with another one.There was no patient harm and the outcome was fine.The surgery was prolonged less than 30 minutes.The procedure was successfully completed.This complaint involves 1 part.Concomitant reported parts: a 1x impactor f/pfna blade (part 356.823 lot unknown).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

The device was received and the product evaluation is in progress.No conclusion can be drawn.Corrected data: udi: (b)(4).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

Additional narrative: a manufacturing investigation was performed.The product was returned in a packaging different from the original packaging.The laser marking was readable.Traces of repeated use were visible; sleeve of the blade shows slight repeated traces on the surface.Two cutting wings are damaged on the top.Dimensions of the blade and its components (sleeve, endcap and screw) were checked according the drawings.Feature internal hexagon of the screw is damaged.Therefore, the measurement 12 has failed through the gauge.However, this damage (internal hexagon) was not caused by manufacturing process.The blade can be locked according to its use; without applying strong force.According to the investigation results, the blade meets its specifications and no manufacturing issue was found.This complaint is unconfirmed due to the blade received could be assembled and be locked.The dimensions and material of the received blade received were checked and the product was manufactured according to its specifications.No manufacturing related issue was identified and/or confirmed.(510k): device is not distributed in the united states, but is similar to device marketed in the usa.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 BLADE PERF L95 TAN
• Type of Device: APPLIANCE,FIXATION,NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT
• 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: 6622467
• MDR Text Key: 77450063
• Report Number: 9612488-2017-10247
• Device Sequence Number: 1
• Product Code: KTW
• 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,Followup
• Report Date: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• 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: L330391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 45 YR