MAUDE Adverse Event Report: SYNTHES (USA); EXTRACTOR

Device Problem Break (1069)

Patient Problem Discomfort (2330)

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported a patient that underwent previous bi-lateral total knee replacement (tkr) of the right and left knee returned to the doctor on (b)(6) 2013 for a follow up examination regarding the tkr.The patient fell, on an unknown date and x-ray revealed the patient suffered a periprostatic fracture on the left knee; the patient underwent an open reduction internal fixation with a locking distal femur plate-9 holes.The patient was discharge on (b)(6) 2013.On (b)(6) 2014 the patient was readmitted with complaints of discomfort on the left knee.X-rays revealed the patient refractured the left knee along with a broken device.The patient walks with partial weight bearing with walking support aid.Per additional information received on (b)(6) 2014, the patient underwent an open reduction internal fixation revision surgery on (b)(6) 2014 on the left knee with a lcp (b)(4) distal femur plate-9 holes and 5.0mm locking screws x 15.This report is on an unknown screw.This is report 2 of 4 for complaint (b)(4).

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device used for treatment not diagnosis.This report is for an unknown screw.The part was received; an evaluation is currently in progress.The lot number is unknown; therefore, a review of the device history record could not be completed.

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.A manufacturing evaluation was completed: a broken off part of unknown extraction screw is jammed in a locking screw head.A manufacturing conclusion cannot be presented due to the condition of the product.Visually there does not appear to be an issue other than the damage sustained by mechanical overloading.(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.

• 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: 3702073
• MDR Text Key: 19299492
• Report Number: 2520274-2014-10461
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/24/2014

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2014
• Initial Date FDA Received: 03/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/07/2014
• 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 Outcome(s): Required Intervention
• Patient Weight: 67