MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS BATT-HANDPIECE RECON SAGITTAL SAW W/T-HA; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 05.001.240

Device Problems Device Inoperable (1663); Defective Component (2292); Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device was returned for service however did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and observed that the coupling tool side was not functioning.It was further reported that the thread was torn in the tensioning screw.Therefore, the reported condition was confirmed.The assignable root cause could not be determined.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported from (b)(6) that during service and evaluation, it was discovered that the coupling tool side was defective on the battery handpiece device.It was noted in the service order that the thread was torn in the tension screw and the tension screw did not work at all on the device.The event was not related to surgery.There was no patient involvement reported.There were no injuries, delays, or medical intervention associated with this event.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: BATT-HANDPIECE RECON SAGITTAL SAW W/T-HA
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5241133
• MDR Text Key: 32011371
• Report Number: 3009450871-2015-14368
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2015
• Initial Date Manufacturer Received: 11/16/2015
• Initial Date FDA Received: 11/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1