MAUDE Adverse Event Report: SYNTHES GMBH SAW BLADE 55/40*54*0.6/0.4; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number 532.071

Device Problem Dull, Blunt (2407)

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

Event Date 02/08/2022

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.The lot/serial number is unknown.Concomitant med products and therapy dates: saw blade device; (b)(6) 2022.The reporter¿s phone number and complete facility address were not provided.The device manufacture date was unknown.Device evaluation: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi: (b)(4).

Event Description

Report 1 of 2 of the same event: it was reported from (b)(6) that during an unspecified surgical procedure, it was discovered that the saw blade stopped working.According to the reporter, the saw showed weakness and could not deal with cutting the bone quickly.It was reported that a second saw blade device was used to continue the surgery, however the same problem occurred.It was reported that a spare device was available to complete the surgery.It was not reported if there were any delays to the surgical procedure.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• 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: 13654166
• MDR Text Key: 290783864
• Report Number: 8030965-2022-01264
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.071
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1