MAUDE Adverse Event Report: SYNTHES GMBH STERNUM TOP FOR RECIP SAW ATTACHMENT; BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL

Catalog Number 511.904

Device Problems Device Slipped (1584); Premature Separation (4045)

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

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Concomitant medical products: sternum top for recip saw attachment and reciprocating saw attachment, therapy date: (b)(6) 2020.Udi: (b)(4).

Event Description

This is event 2 of 3 of the same event.It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the sternum top device for the reciprocating saw attachment device loosened itself twice from the saw attachment for the trauma recon system.It was unknown if there were any delays to the surgical procedure or if a spare device was available for use.There was patient involvement.It was reported that there was no parts left inside the patient.There were no 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

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained, that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The actual device was returned for evaluation.  quality engineering evaluated the device.And it was determined, that it was difficult to connect an allen key, however it was still possible.And the hook could be tightened properly to dedicated reciprocating saw attachment.It was further determined, that the device failed visual assessment for the locking screw.Therefore, the reported condition was confirmed.The assignable root cause was traced to component failure, due to normal wear.A device history review was performed, and no non-conformances were detected related to the reported condition.

• Brand Name: STERNUM TOP FOR RECIP SAW ATTACHMENT
• Type of Device: BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11108339
• MDR Text Key: 225105015
• Report Number: 8030965-2021-00001
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 07611819118768
• UDI-Public: 07611819118768
• Combination Product (y/n): N
• PMA/PMN Number: K971544
• 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: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 511.904
• Device Lot Number: MA1061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Date Manufacturer Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1