MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC LID FOR BATTERY HANDPIECE MODULAR, TRS; BATTERY, REPLACEMENT, RECHARGEABLE

Catalog Number 05.001.227

Device Problems Device Operates Differently Than Expected (2913); Mechanical Jam (2983)

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

Event Date 03/21/2018

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.The lot/serial number and date of manufacture were unknown.Therefore, udi: lot/serial unknown.(b)(4).The manufacturing location was unknown.(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

This is report 2 of 2 for the same event.It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the handpiece device and lid device had become blocked while in use together.It was reported that there was no delay in the procedure due to the event, as an unspecified 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.

• Brand Name: LID FOR BATTERY HANDPIECE MODULAR, TRS
• Type of Device: BATTERY, REPLACEMENT, RECHARGEABLE
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): N/I; n/i; n/i
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7437463
• MDR Text Key: 105711007
• Report Number: 8030965-2018-53173
• Device Sequence Number: 1
• Product Code: MOQ
• UDI-Device Identifier: 7611819978041
• UDI-Public: (01)7611819978041
• 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
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.227
• Device Lot Number: N/I
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2018
• 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