MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ANGLED RMR DRIVER HUDSON; HIP INSTRUMENTS : ADAPTORS

Model Number 9200-10-031

Device Problems Device Damaged Prior to Use (2284); Device-Device Incompatibility (2919); Appropriate Term/Code Not Available (3191)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 06/09/2020

Event Type  malfunction  

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.

Event Description

Instrument was delivered broken.It could not be used.This impacted the flow of the surgery and time was lost.Potential adverse event as the right material was not placed.Note: 3rd party which is delivering the orthokits had also been informed about this complaint (etq-complaint reference com-352717).

Manufacturer Narrative

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: h6 (patient and device codes) h6 patient code: no code available (3191) used to capture the surgery prolonged and insufficient information.H6 device code: no code available (3191) used to capture the customer feedback: dissatisfaction if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint #
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> pc(b)(4) investigation summary
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> review of the photo could not confirm the failure mode.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.H10 additional narrative: added: e1 (facility name).

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

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: d10 corrected: h3 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: review of the photo could not confirm the failure mode.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.

Manufacturer Narrative

Product complaint # (b)(4).Re-opened as device was received in 28 aug 2020.Investigation summary examination of the returned instrument cannot confirm the complaint.Depuy-synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.

• Brand Name: ANGLED RMR DRIVER HUDSON
• Type of Device: HIP INSTRUMENTS : ADAPTORS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10198245
• MDR Text Key: 196578968
• Report Number: 1818910-2020-14470
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 10603295221906
• UDI-Public: 10603295221906
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/09/2020

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: 9200-10-031
• Device Catalogue Number: 920010031
• Device Lot Number: MJ3643001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• Initial Date Manufacturer Received: 06/09/2020
• Initial Date FDA Received: 06/25/2020
• Supplement Dates Manufacturer Received: 06/09/2020; 07/06/2020; 08/10/2020; 09/01/2020; 08/28/2020; 11/13/2020
• Supplement Dates FDA Received: 07/03/2020; 07/07/2020; 08/14/2020; 09/01/2020; 09/17/2020; 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1