MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS BROACH SZ 4; BROACHES

Model Number 2010-01-040

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Nerve Damage (1979)

Event Date 12/08/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Surgeon informed sales rep "patient received hip-tep.The malfunction has been reported to have occurred during : intra-op, and involved : patient reported injuries : patient is now suffering from peroneal lesion and floppy foot.Patient´s left hip is affected.Surgery delay : no report of surgery delay has been made at this time medical intervention : no report of medical intervention has been made at this time other information on the surgery/event : an actis rasp sz.4 was used, an actis stem sz.4 was implanted.Doi: unk, dor: unk, left hip.

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.

Event Description

Additional information was received indicating that "patient consulted neurologist.According to the neurologist, the patient has a lesion of the peroneal nerve.This was due to damage to the positioning during the operation.For this reason, the patient is currently wearing a splint.The patient has no problems with her hip.She is doing well.".

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: dhr review: 1) quantity manufactured: (b)(4).2) date of manufacture: 5/29/2019 3) any anomalies or deviations identified in dhr: n/a.4) expiry date: n/a.5) ifu reference: (b)(4).

• Brand Name: ACTIS BROACH SZ 4
• Type of Device: BROACHES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 13167728
• MDR Text Key: 283236348
• Report Number: 1818910-2022-00154
• Device Sequence Number: 1
• Product Code: HTQ
• UDI-Device Identifier: 10603295393665
• UDI-Public: 10603295393665
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2010-01-040
• Device Catalogue Number: 201001040
• Device Lot Number: PG292454
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female