MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS RECIP SAW BLADE DOUBLE-SIDED LGTH 68MM/CUT THK 0.80MM-STER; BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL

Catalog Number 511.914S

Device Problems Detachment Of Device Component (1104); Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported in (b)(6) that during a knee replacement surgery, it was discovered that the tip of the saw blade device was ¿torn off¿.According to the reporter, the malfunction had occurred in several cases.However, the reporter was unable to specify the specific amount of occurrences or the number of patients involved.It was not reported if there were any delays in a surgical procedure or if a spare device was available.There was patient involvement reported.It was reported that this event was not relevant to the health of the patient.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

(b)(6).The manufacturing location was unknown.The lot number was unknown.Therefore, device manufacture date is unknown.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: RECIP SAW BLADE DOUBLE-SIDED LGTH 68MM/CUT THK 0.80MM-STER
• Type of Device: BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; ni
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; ni; ni; ni
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4309814
• MDR Text Key: 5134191
• Report Number: 2520274-2014-15075
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 511.914S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2014
• 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
• Patient Sequence Number: 1