MAUDE Adverse Event Report: SYNTHES USA; SCREW, FIXATION, BONE

Device Problems Flaked (1246); Metal Shedding Debris (1804)

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

Event Date 01/23/2015

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the surgeon discovered thin needle-like metal flakes during a procedure on (b)(6) 2015.The flakes were first noticed right after the insertion of one of the variable angle buttress pins into the distal plate during the palmer side plate procedure.The flakes were sharp and twisted in a round shape.They were then discovered when the surgeon inserted the buttress pin into a different hold for the dorsal plate.As it turned out, the surgeon was drilling holes although the angle-adjustable sleeve had not meshed with the screw holes completely.Surgery was completed with no reported time delay or patient harm.This report is for one (1) unknown 2.4mm variable angle locking screw.This report is 2 of 3 for (b)(4).

Manufacturer Narrative

Patient identifying information is not available for reporting.This report is for one (1) unknown 2.4mm variable angle locking screw.Per facility, materials are not available for return and investigation.Pma 510(k): unknown, as no lot or part numbers were provided for this complainant part.Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number or part number was provided.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.

• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4495790
• MDR Text Key: 17297106
• Report Number: 2520274-2015-10865
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 01/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2015
• 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