MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 SIGMA HP 0DEG RT CUT BLK; CUTTING BLOCK

Model Number 9505-01-223

Device Problem Device-Device Incompatibility (2919)

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

Event Date 02/22/2022

Event Type  malfunction  

Event Description

It was reported that the drill bit became bound up and stuck in the tibial cutting block.No surgical delay.No additional information.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was returned for examination.Visual examination of the returned device confirmed the allegation.The drill is stuck at the cutting block.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.Device history lot: a manufacturing records evaluation (mre) was not performed since a valid finished good lot number was not provided for this device.

• Brand Name: SIGMA HP 0DEG RT CUT BLK
• Type of Device: CUTTING BLOCK
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13710451
• MDR Text Key: 288187454
• Report Number: 1818910-2022-04292
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10603295225287
• UDI-Public: 10603295225287
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9505-01-223
• Device Catalogue Number: 950501223
• Device Lot Number: J0808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1