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

Catalog Number	511.904
Medical Device Problem Codes	Device Slipped (1584); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Concomitant devices: sternum top for recip saw attachment and reciprocating saw attachment, therapy date: (b)(6) 2020.Udi: (b)(4).
Event or Problem Description
This is event 3 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.
Additional 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 the device passed all operational specifications and no failure was identified.Therefore, the reported condition was not confirmed, and an assignable root cause was not determined.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
• Common Device Name: BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11108353
• Report Number: 8030965-2020-10023
• Device Sequence Number: 3698079
• Product Code: GFA
• UDI-Device Identifier: 07611819118768
• UDI-Public: 07611819118768
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K971544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2020

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
• Operator of Device: Health Professional
• Device Catalogue Number: 511.904
• Device Lot Number: MA1063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1