MAUDE Adverse Event Report: SYNTHES USA WASHER 13.0MM; BOLT, NUT, WASHER

Catalog Number 419.99

Device Problem Material Fragmentation (1261)

Patient Problem No Code Available (3191)

Event Date 01/08/2016

Event Type  Injury  

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

Patient alternate id: (b)(6).Patient initials: (b)(6).Patient weight not available for reporting (b)(4).Device broke intra-operatively and was not implanted / explanted utilized to report unintended imagining to confirm fragment removal 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.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

It was reported that a washer broke when the surgeon was tightening a screw during a hip pinning procedure.Part of the washer broke off in the patient however all fragments were retrieved.There was a five (5) minute surgical delay caused to retrieve the washer fragments.The patient underwent an intra-operative x-ray, and it was noted that all fragments were removed.Procedure completed successfully with no harm to patient.There is currently no additional information at this time.This is report 1 of 1 for (b)(4).

• Brand Name: WASHER 13.0MM
• Type of Device: BOLT, NUT, WASHER
• 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: 5384993
• MDR Text Key: 36616694
• Report Number: 2520274-2016-10385
• Device Sequence Number: 1
• Product Code: HTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PPREAMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 419.99
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR