MAUDE Adverse Event Report: SYNTHES GMBH OSCILLATING SAW ATTACHMENT II; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number 511.801

Device Problems Device Markings/Labelling Problem (2911); Mechanical Jam (2983); Complete Loss of Power (4015)

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

Event Date 09/12/2022

Event Type  malfunction  

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.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 lot number was not visible; therefore, the device manufacture date is unknown, and the udi is incomplete.The manufacturing site name is currently not available.Device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device being frozen/would not move, identified during service and evaluation were confirmed.The assignable root cause was determined to be due to component failure from wear.Udi: (b)(4)unknown.

Event Description

It was reported by india that during service and evaluation, it was determined that the oscillating saw attachment was frozen/would not move and had component damage.It was observed that the labeling had an illegible etch.It was further determined that the device failed pretest for marking and labeling, check the handpiece coupling, check symmetry with handpiece, check function in running mode and check the oscillation frequency with frequency meter.It was noted in the service order that the device was not working.It was reported that the device was used in an orthopedic procedure.However, it was not reported whether the issue occurred during surgery.It was unknown whether there was patient involvement.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 will be submitted accordingly.

• Brand Name: OSCILLATING SAW ATTACHMENT II
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 15579466
• MDR Text Key: 307064846
• Report Number: 8030965-2022-08026
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 07611819102262
• UDI-Public: 07611819102262
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 511.801
• Device Lot Number: NOT VISIBLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1