STRYKER 29637

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-29 for STRYKER 29637 manufactured by Stryker Surgical.

Event Text Entries

[18952580] The saw became hot as the surgeon was sawing the mandible. No other instrument was available. While completing the procedure the body of the instrument burned a spot the size of a quarter on the pts lower lip. Device not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced:. Service provided by: manufacturer. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: mechanical problem, telemetry failure, unanticipated short term complication of procedure, invalid data. Conclusion: device was out of spec in a manner that relates to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device returned to manufacturer/dealer/distributor. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9065
• MDR Report Key: 9065
• Date Received: 1994-07-29
• Date of Report: 1994-01-07
• Report Date: 1994-01-07
• Date Added to Maude: 1994-11-23
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: STRYKER
• Generic Name: RECIPRICATING SAW
• Product Code: HSO
• Date Received: 1994-07-29
• Model Number: 29637
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: N
• Device Age: 01-JAN-94
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 8725
• Manufacturer: STRYKER SURGICAL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1994-07-29