MAUDE Adverse Event Report: SYNTHES (USA) EXTRACTION SCREW FOR 5.0MM SCREWS-STERILE; EXTRACTOR

Catalog Number 03.223.020S

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Event Description

Device report from synthes (b)(6) reports an event in (b)(6) as follows: it was reported during a scheduled implant removal for hardware implanted two years prior to this report date the surgeon identified two out of three dynamic locking screws (dls) were broken.A broken plate was also present in an x-ray view submitted with this event which reportedly may have been the reason for this revision.The hardware implanted two years ago was due to healing failure of original hardware implanted five years prior to the revision for a distal femoral c2 fracture.It is unknown if the original hardware was synthes product as the surgery was performed at a different facility.The revision surgery included a cancellous bone graft supplemented with dbx (a bone graft substitute) inserted at the level of the distal shaft component, and the proximal screws in the shaft section were removed and replaced with three dls screws, which were inserted in the topmost three plate holes at the upper end of the plate.Reportedly after removal of the plate during the removal of the broken devices the surgeon removed one of two with no difficulty using the extraction screw tool.During the secondary removal the surgeon had to over-drill one side of the cortical bone in the traditional way and use the sleeve with integrated left-hand thread (placed over the screws to easily remove the screw.There was a reported delay of minutes, however the amount of time is unknown.An image reading of the x-rays was conducted by a medical director from this manufacturer which reported: i reviewed the complaint description, letter of surgeon, and enclosed images.I can¿t confirm the screw breakage.According to the complaint, the screw breakage was identified during a surgery in 2014.I saw plate breakage in the image file named ¿x-ray taken 5 months after accident¿ note: one of the x-rays was sent for review without the date included, according the original x-ray data submitted by the surgeon the plate breakage confirmed by the image reading was the x-ray dated (b)(6) 2014 titled ¿x-ray taken 5 months after accident¿ this is report 3 of 4 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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

Product investigation evaluation: the surgeon was not able to extract dls sleeve 5.0 with the extraction screw ø 4 mm (03.223.020s).Reason: the sleeve was damaged (split) due to a mechanical overload.The intended condition for use of instrument was not matched.The sleeve could finally be removed with the intended left handed extraction bolt (309.490) according to the depuy synthes screw extraction procedure described in tech guide.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: EXTRACTION SCREW FOR 5.0MM SCREWS-STERILE
• Type of Device: EXTRACTOR
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4320552
• MDR Text Key: 5133879
• Report Number: 2520274-2014-15251
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.223.020S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2015
• Initial Date FDA Received: 12/11/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/01/2015; 06/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 30 YR