MAUDE Adverse Event Report: SYNTHES GMBH UNK - EXTRACTION INSTRUMENTS: TFNA/PFNA; EXTRACTOR

Device Problem Device-Device Incompatibility (2919)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown extraction instruments: tfna/pfna/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: cao, m.D., yang, z.M.And lu, h.D.(2020), a succinct technique for the extraction of the proximal femoral nail anti-rotation (pfna) after unlocking failure: a case report, journal of orthopaedic surgery and research, vol.15 (300), pages 1¿4 (china).This study presents a case report of a (b)(6)-year-old female patient who sustained an intertrochanteric femoral fracture on the left side.She was treated with routine closed reduction, fixation with proximal femoral nail anti-rotation (pfna).Fifteen months later, the patient underwent removal of implant per request.During the first part of the procedure, the end cap and distal locking bolt were successfully removed.However, when we tried to remove the anti-rotation blade following the instructions (fig.2), it was found that the hexagonal socket slipped (fig.3) and could not lock up with the extraction screw for pfna blade.Therefore, the locking blind nut could not dispatch with the main body of the anti-rotation blade.After loosening the attachment of the blade and the greater trochanter, locking pliers were used to pull out the blade.However, the pliers could not provide enough tensile.Not only that, multiple failed attempts were made to remove the nail with conventional techniques.Thus, a unicortical hole was drilled by a 5-mm tungsten carbide bur at the end of the blade, and a 2-mm double-strand steel wire was threaded through the previously drilled hole (fig.4 a and b).The wire was twisted and strongly tied up to the extraction screw by hard loop.Eventually, the blade was removed by applying blows of the combined hammer, in the direction of the blade.The post-operation x-ray (fig.5) showed the implants were utterly removed.The patient was encouraged to take full weight 2 weeks after surgery with anti-osteoporosis treatment.This report is for an unknown synthes pfna extraction instruments.This is report 2 of 2 for (b)(4).

• Brand Name: UNK - EXTRACTION INSTRUMENTS: TFNA/PFNA
• Type of Device: EXTRACTOR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11348121
• MDR Text Key: 233034081
• Report Number: 8030965-2021-01157
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/29/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/19/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR