MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ANGLED ACET INSERTR; HIP INSTRUMENTS : INSERTION DEVICES

Model Number 9200-10-029

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 03/09/2021

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

It was reported that on (b)(6) 2021, the patient underwent tha surgery for osteoarthritis for the right side.During the surgery, the surgeon found that the anti-rotation button of the inserter in question was broken and he could not lock it.The surgery was delayed by less than 30 minutes.The product had been already broken before the surgery.No further information is available.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned.However, a review of a provided photograph found a different failure than what was reported.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 review : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned.However, a review of a provided photograph found a different failure than what was reported.The investigation could not verify or identify any product contribution to the reported event with the information provided.Depuy synthese 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 review: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned.However, a review of a provided photograph found a different failure than what was reported.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 review: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ANGLED ACET INSERTR
• Type of Device: HIP INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 11555688
• MDR Text Key: 241899522
• Report Number: 1818910-2021-05872
• Device Sequence Number: 1
• Product Code: HWR
• UDI-Device Identifier: 10603295221890
• UDI-Public: 10603295221890
• 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
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9200-10-029
• Device Catalogue Number: 920010029
• Device Lot Number: MJ3580801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Date Manufacturer Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1