MAUDE Adverse Event Report: SYNTHES (USA) CONICAL EXTRACTION SCREW FOR 1.5MM & 2.0MM CORTEX SCREWS; EXTRACTOR

Catalog Number 309.510

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/13/2015

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).Device is an instrument and is not implanted/explanted.It is not known if the subject device will be returned to the synthes manufacturer for evaluation.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.

Event Description

It was reported that, on (b)(6) 2015 the patient underwent an initial implant surgery for open reduction internal fixation of the proximal tibia.During the procedure, a 3.5 locking screw cold welded to the medial proximal tibial plate.The surgeon wanted to change the screw, which he determined was too long, but was not able to back it out of the plate.He then attempted to remove the screw with a stardrive screwdriver, but the shaft torqued and bent.A conical extraction bolt from a screw removal set was then used in an attempt to remove the screw; however, the tip of the extraction bolt broke off in the screw recess.The surgeon decided to leave the tip in the patient.He was not able to extract the screw.There was a ten minute surgical delay.The procedure was successfully completed and the patient postsurgical outcome was reported as "fine".This report is 1 of 2 for (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.

Event Description

This report is 1 of 1 for (b)(4).

• Brand Name: CONICAL EXTRACTION SCREW FOR 1.5MM & 2.0MM CORTEX SCREWS
• 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: 5268431
• MDR Text Key: 32737576
• Report Number: 2520274-2015-17685
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/13/2015

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: 309.510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/13/2015
• Initial Date FDA Received: 12/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/09/2015
• 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