MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC BATTERY HANDPIECE/MODULAR FOR TRS; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 05.001.201

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Reporter's phone number: (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.

Event Description

It was reported from (b)(6) that during a surgical procedure of the knee it was observed that the handpiece device stopped working.It was not reported if there was delay in the procedure due to the event, or if a spare device was available for use.There was patient involvement reported.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 will be submitted accordingly.

Manufacturer Narrative

Device was used for treatment, not diagnosis.The device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the housing of the handpiece device was cracked.It was further determined that the device failed pretest for check for leakage, and general condition.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to improper handling, which is user error/misuse/abuse.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: BATTERY HANDPIECE/MODULAR FOR TRS
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES PRODUKTIONS GMBH; hauptstrasse 24; waldenburg 4437 ; SZ 4437
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7151222
• MDR Text Key: 95956941
• Report Number: 8030965-2017-50986
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 7611819977815
• UDI-Public: (01)7611819977815(11)150914
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• 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,Followup
• Report Date: 12/06/2017

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: 05.001.201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 04/20/2018
• Supplement Dates FDA Received: 04/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2015
• 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