MAUDE Adverse Event Report: SYNTHES GMBH LID-HANDPIECE/MODULAR FOR TRS; BATTERY, REPLACEMENT, RECHARGEABLE

Catalog Number 05.001.231

Device Problem Premature Separation (4045)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Concomitant med products and therapy dates: battery handpiece/modular device, (b)(6) 2021.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Reference manufacturer report number: 8030965-2021-08111 for report 1 of 2 of the same event.Udi: (b)(4).

Event Description

This is report 2 of 2 of the same event: it was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the lid device was released from the battery handpiece/modular device when used in saw mode and cutting the bone due to the pressure exerted on the bone.It was reported that there was an unspecified surgical delay.It was not reported whether a spare device was available for use.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.However, it was reported that the event occurred in 2021.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Device evaluation: this device was returned for evaluation.A visual and functional assessment was performed which determined that the device passed all pre-repair diagnostic assessments and no failures were identified.Therefore, the reported condition was not confirmed, and an assignable root cause was not determined.

• Brand Name: LID-HANDPIECE/MODULAR FOR TRS
• Type of Device: BATTERY, REPLACEMENT, RECHARGEABLE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12554077
• MDR Text Key: 274010473
• Report Number: 8030965-2021-08151
• Device Sequence Number: 1
• Product Code: MOQ
• UDI-Device Identifier: 07611819474901
• UDI-Public: 07611819474901
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Date Manufacturer Received: 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1