MAUDE Adverse Event Report: SYNTHES BETTLACH EXTRACTSCR F/PFNA BLADE; EXTRACTOR

Catalog Number 03.010.411

Device Problems Break (1069); Metal Shedding Debris (1804)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information was not provided by reporter.Device is an instrument and is not implanted/explanted.(b)(4).Device is not distributed in the united states, but is similar to device marketed in the usa.A device history record review was performed for the subject device lot.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.The subject device has been received and is currently in the evaluation process.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) reported an event the (b)(6) as follows: it was reported that a patient underwent a surgical procedure for a proximal femoral nail antirotation (pfna) blade to be removed.The reported pfna impactor instrument that was utilized was broken prior to the procedure, with screw-like threads present on the end of the device.As a result, the pfna blade could not be removed.The patient was closed up and underwent a separate procedure on another date with a complete loan-set.The pfna impactor used for this procedure had previously been returned to the manufacturer for inspection.The inspection of the device did not capture the threads, which allowed for the device to be prematurely returned to the customer and ultimately used for a case.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Initial reporter: phone number: (b)(6) a product investigation was completed: the investigation has shown that the threaded tip of the extraction screw is broken off as complained.Unfortunately, the specific clinical situation at the time of breakage is not known.The review of the production histories revealed that this instrument was manufactured in september 2013 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.No manufacturing related issues that would have contributed to this complaint were found.On the returned instrument the relevant dimensions could not be measured due to the damage incurred.Since the information given did not provide sufficient evidence the cause of failure could not definitely be determined; however, a material or manufacturing related issue can be excluded.There was no indication for material or design related issue.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 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: EXTRACTSCR F/PFNA BLADE
• Type of Device: EXTRACTOR
• 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: 5112485
• MDR Text Key: 27053666
• Report Number: 9612488-2015-10489
• Device Sequence Number: 1
• Product Code: HWB
• 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: Physician
• Type of Report: Followup,Followup
• Report Date: 01/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.411
• Device Lot Number: 8446885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/09/2015; 11/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention