MAUDE Adverse Event Report: SYNTHES GMBH UNKNOWN SAW BLADES; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number UNK-SAW-BLADES

Device Problem Dull, Blunt (2407)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 12/01/2020

Event Type  Injury  

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.Additional narrative: the brand name, catalog number, lot number, and device manufacture date were unknown.Pma/510(k) number is unknown.Concomitant med products and therapy dates: lid device, battery handpiece/modular device, reciprocating saw attachment device, (b)(6) 2020.As of this date, the device has not been returned for evaluation, therefore, the reported condition cannot be confirmed, and/or duplicated.Udi: the part number is unknown; therefore, the gtin is unknown.A udi cannot be generated.

Event Description

This is report 3 of 3 of the same event: it was reported from france that during a thoracic surgical procedure, it was discovered that during a bone sawing, the battery handpiece/modular device had lack of power, and then the safety system activated when the device was placed under the sternum.It was further reported that when the saw device finally turned on again after several attempts of reassembly, the reciprocating saw attachment device (with the saw) became detached from the handpiece.It was reported that the first reusable saw blade did not cut, and the handpiece, attachment, and reusable saw were replaced.It was further reported that the sternotomy was incorrect ¿crooked sternotomy¿ causing the section of the sternocostal cartilages instead of the sternum.According to the reporter, the cartilage was cut following the detachment of the attachment (with the saw) of the handpiece which fell inside the patient.The reporter indicated that the consequence of the issue could have been a vital risk because of the zone with the risk of a hemorrhage.It was reported that the event resulted in a delay in surgery and an extended time of apnea imposed on the patient.However, the duration of the delay was not specified.It was further reported that knifes were used to replace the sternum as a medical intervention.There was patient involvement reported.There was patient injury and medical intervention reported as a result of this event.It was not reported whether there was prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: UNKNOWN SAW BLADES
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6107428552
• MDR Report Key: 11040691
• MDR Text Key: 222647098
• Report Number: 8030965-2020-09867
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK-SAW-BLADES
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention