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

Catalog Number 03.037.032

Device Problem Mechanical Jam (2983)

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

Event Date 01/23/2017

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).Device is an instrument and is not implanted/explanted.The subject device has been received and is currently undergoing investigation.A device history record review was performed for the subject device lot.Manufacturer: synthes (b)(4).Date of manufacture date: jan 22, 2015.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that a nail extractor was used to remove a 11mm/130 degree titanium cannulated trochanteric fixation nail advance 170mm ¿ sterile (tfna) nail during a revision surgery held on (b)(6) 2017, see related (b)(4).There were no issues with device removal reported during the surgery.However, upon receiving the two (2) devices from sterile processing on (b)(6) 2017, it was found that the nail extractor and tfna nail were stuck together and remain that way.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Product development investigation has been completed.Device history record (dhr) review, visual inspection and drawing review were performed as part of this investigation.The complaint condition is confirmed as the extractor and nail were received stuck together and could not be separated.Witness marks consistent with implant were observed on the surfaces of the proximal and distal holes of the nail.The balance of the each device shows light surface wear and is in functional condition.The threaded region of each device could not be inspected as the devices could not be separated.Replication of the complaint condition is not applicable as the devices could not be separated.The returned nail and nail extractor are part of the trochanteric fixation nail advanced (tfna) system and referenced in the tfna technique guide.The extractor is used for nail removal by being threaded into the top of the nail.Relevant drawings were reviewed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended.No definitive root cause was able to be determined.However, the condition appears consistent with galling or cross threading of the thread junction causing the parts to adhere together and preventing disassembly.Corrected data: date of event is unknown.Device was used on (b)(6) 2017 during the surgery and was found stuck on (b)(6) 2017.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 HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6343043
• MDR Text Key: 67933036
• Report Number: 3003875359-2017-10074
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982070487
• UDI-Public: (01)10886982070487(10)9343591
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.037.032
• Device Lot Number: 9343591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2015
• 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