MAUDE Adverse Event Report: SYNTHES (USA) LOCK IMPACTOR

Catalog Number 388.493

Device Problems Break (1069); Detachment Of Device Component (1104); Device Inoperable (1663)

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

Event Date 04/13/2011

Event Type  malfunction  

Manufacturer Narrative

Synthes is submitting this report as a result of remediation activities.Device listed in this report is used for treatment, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.Subject device returned and evaluations completed.The manufacturing documents were reviewed and no complaint related issues were found.A manufacturer evaluation reported one corner of the flange is broken off, both flange are bent outward which made a proper function impossible.Also the holding edges were found completely blunt and worn out.Device shows evidence of excessive due to wear and tear usage.It concluded: no manufacturing related fault detected.

Event Description

The hospital implant coordinator reported an event occurred on (b)(6) 2011 during a veptr procedure while the surgeon was using the rib expansion pliers; the surgeon was lengthening the rib when the peg on the side of the pliers broke off and could not be retrieved.The surgeon selected another instrument to complete the rib lengthening.Later in the procedure, the surgeon was using the lock impactor and the impactor would not hold the lock.The surgeon selected another lock impactor and completed the procedure.No report of harm to patient or delay in surgery noted.This complaint is for one lock impactor.This is report 1 of 1 for complaint #(b)(4).

• Brand Name: LOCK IMPACTOR
• Manufacturer (Section D): SYNTHES (USA); west chester PA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19830 ; 6107195000
• MDR Report Key: 4929760
• MDR Text Key: 22507118
• Report Number: 2520274-2014-06600
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Report Date: 04/14/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 388.493
• Device Lot Number: 1191714
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/28/2011
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2003
• 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