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

Catalog Number UNK SAW BLADE

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 07/14/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the tip of the blade broke while cutting posterior chamfer during tka.A surgical delay of 2 minutes was noted.No additional information was available.Doe: (b)(6) 2020; left knee.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.

Event Description

Additional information received stated that the device broke into 2 pieces that were retrieved successfully.

Manufacturer Narrative

Product complaint # (b)(4).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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative:  added: b5, d4 (lot).Corrected: h8.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: UNK SAW BLADE
• Type of Device: UNKNOWN SAW BLADE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10315991
• MDR Text Key: 201049191
• Report Number: 1818910-2020-16738
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SAW BLADE
• Device Lot Number: 011696
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/14/2020
• Initial Date FDA Received: 07/23/2020
• Supplement Dates Manufacturer Received: 07/14/2020; 08/10/2020
• Supplement Dates FDA Received: 08/05/2020; 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR