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

Catalog Number UNK-SAW-BLADES

Device Problem Excessive Heating (4030)

Patient Problem Burn(s) (1757)

Event Date 01/01/2020

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.The brand name, catalog number, lot number, and device manufacture date were unknown.Pma/510(k) number was unknown.Concomitant med products and therapy dates: oscillating saw device, small battery drive device.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 (b)(6) that during an arthroscopy surgical procedure, it was discovered that while the small battery drive device was being used together with the oscillating saw device and the saw blade devices, the oscillating saw touched the patient¿s skin causing a burn.It was further indicated that the patient experienced a second degree burn.According to the reporter, the surgeon placed the oscillating saw directly on the patient's skin, and after a continuous use of five minutes without interruption, the device burned the patient¿s skin, cutting the skin and muscles to the bone.According to the reporter, the facility stated that they were aware that the, "colibri ii manual, does it mention use for 30 seconds and leave 60 seconds for cooling." it was further reported that the facility acknowledged the device was misused.It was reported that there were no delays in the surgical procedure.It was not reported if a spare device was available for use.There was patient involvement reported.There was patient injury reported.According to the reporter, the patient is currently doing well.The burn caused a blister and as such, the patient was treated by the hospitals burn team.There was no additional information available regarding additional medications provided to the patient due to the burn.It was not reported if there was any prolonged hospitalization required as a result of this event.The exact date of the event was unknown.However, it was reported that the event occurred in 2020.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: 10906246
• MDR Text Key: 218658399
• Report Number: 8030965-2020-09219
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• 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: 10/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention