MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK SAW BLADE

Catalog Number UNK SAW BLADE

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 03/01/2004

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

The literature article entitled, "saw tooth fracture in total knee arthroplasty" written by w.M.Tang, frce, ky chiu, frcsed, and t.P.Ng, frcse published by orthopedics march 2004 volume 27 and number 3 was reviewed.The article's purpose is to report on 2 case reports in which a depuy stablecut saw-blade experienced a malfunction.Each case is captured individually in linked complaints.This complaint captures case 1 of a (b)(6) woman who underwent bilateral knee tka with lcs system (depuy.The stablecut saw blade was utilized and a loud metal-hitting-metal sound was heard along with strong vibration returned from the saw.The surgeons proceeded to finish tka procedure and close the wound.Radiographs reveal left knee had two small, radio-opaque objects with sharp edges.Under femoral nerve block, the objects were retrieved with arthroscopic forceps under image intensifier and were confirmed to be two broken saw teeth.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint #: (b)(4).Investigation summary: no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNK SAW BLADE
• Type of Device: SAW BLADE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9480273
• MDR Text Key: 177404094
• Report Number: 1818910-2019-123323
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SAW BLADE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention