MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS BROACH SZ 8; BROACHES

Model Number 2010-01-080

Device Problems Break (1069); Material Deformation (2976)

Patient Problems No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/23/2020

Event Type  Injury  

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

The male piece of the broach broke off when trying to extract from the patient.The surgery was delayed 30 minutes.The surgery was successfully completed.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary the device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided.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.Patient code: no code available ((b)(4)) is used to capture insufficient information and prolonged surgery.Device code: removed code for material deformation.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary : the device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided.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 record evaluation (mre), was not possible because the required lot code was not provided.

Event Description

Additional information received indicated that they have to chip away a window of bone to extract the broach with a vice.

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 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h1 and h6 (clinical and impact codes) h6 clinical symptoms code: appropriate term/code not available (e2402) used to capture bone injury.

• Brand Name: ACTIS BROACH SZ 8
• Type of Device: BROACHES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10653465
• MDR Text Key: 210600301
• Report Number: 1818910-2020-21829
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 10603295393702
• UDI-Public: 10603295393702
• Combination Product (y/n): N
• PMA/PMN Number: K150862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/23/2020

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 Model Number: 2010-01-080
• Device Catalogue Number: 201001080
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/08/2020
• Supplement Dates Manufacturer Received: 11/18/2020; 07/30/2021; 07/14/2021
• Supplement Dates FDA Received: 11/19/2020; 08/02/2021; 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1