MAUDE Adverse Event Report: SYNTHES USA NAIL EXTRACTOR; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 03.037.032

Device Problem Failure To Adhere Or Bond (1031)

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

Event Date 02/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device is an instrument and is not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.(b)(6).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during the broken nail removal surgery performed on (b)(6) 2017, the extraction screw wouldn't engage with the proximal part of the nail and the extractor for the blade would not engage into the threads below the aperture of the nail.There was surgical delay of sixty (60) minutes due to the reported event.Surgeon eventually malleted in this instrument until it cross threaded and gripped onto the nail.New long 14mm 140 degree nail was inserted, fracture was grafted.Patient outcome and surgery outcome not reported.Instruments were faulty.Both instruments mentioned would not easily engage.When they did, the instrument pulled out when back slapping with the mallet.Surgery was completed successfully.This report addresses the intraoperative issues during extraction of the nail.The post-operative event of broken nail has been captured under linked complaint (b)(4).Concomitant medical products: 1.7mm cocr cable with ti crimp 750mm-sterile (part # 611.105.01s, lot # unknown, quantity 1), tfna fenestrated helical blade 85mm - sterile (part# 04.038.385s, lot # 7866730, quantity 1).This is report 2 of 3 for complaint (b)(4).

Manufacturer Narrative

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

A product investigation was completed: the returned implants were evaluated at customer quality and the complaint condition of postoperative breakage (covered in linked complaint (b)(4)) was able to be confirmed however the complaint condition of will not fit with other parts was not able to be replicated or confirmed.The mating extraction instruments were not returned therefore a functional test could not be performed.Additionally, use of the 03.037.030 extractor for blade/screw for removal of the nail was determined to be misuse/abuse as the instrument is only indicated for extraction of the helical blade or lag screw.The tfna technique guide recommends using the 355.399 extraction hook for ti cannulated nails for removal of broken nails.The relevant product drawings were reviewed.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.A device history review was performed for the returned instruments¿ lot numbers and no material record reports, non-conformance reports or complaint-related issues were identified with the lot numbers which may have contributed to the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection, device history record (dhr) review, risk assessment review, and drawing review were performed as part of this investigation.This complaint is unconfirmed.The concomitant part(s) were returned without an alleged complaint condition.Upon visual inspection there is no evidence that this device contributed to the complaint condition.The as received damage on both devices is consistent with implantation and removal.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.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: NAIL EXTRACTOR
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6415293
• MDR Text Key: 70327592
• Report Number: 2520274-2017-10924
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.037.032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: BLADE (PART# 04.038.385S, LOT # 7866730, QTY 1); CABLE (PART # 611.105.01S, LOT # UNKNOWN, QTY 1)