MAUDE Adverse Event Report: SYNTHES HAGENDORF UNIV-CHUCK W/T-HANDLE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 393.100

Device Problems Bent (1059); Loose or Intermittent Connection (1371); Device Inoperable (1663); Dent in Material (2526); Scratched Material (3020)

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

Event Date 10/13/2014

Event Type  malfunction  

Event Description

It was reported from (b)(4) that during an unspecified surgical procedure, it was observed that the universal chuck device did not function.According to the report, the ring of the device was bent and coming loose.It was further reported that the device appeared to be ¿hammered upon¿.The reporter stated there were a lot of scratches and small dents on the device.There were no delays to the surgical procedure as a spare device was available for use.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

(b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device was worn out.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing.If additional information should become available; a supplemental medwatch report will be sent accordingly.

• Brand Name: UNIV-CHUCK W/T-HANDLE
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4221354
• MDR Text Key: 16081957
• Report Number: 3003875359-2014-10338
• Device Sequence Number: 1
• Product Code: HWE
• 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: Foreign,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 393.100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/1998
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1