MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US EXTERNAL ALIGN ANKLE CLAMP; KNEE INSTRUMENT : ALIGNMENT DEVICES

Model Number	2490-49-000
Medical Device Problem Codes	Material Twisted/Bent (2981); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Worn instruments identified by sterilization department, items are new consignment sent to the hospital.The locking wheel is cold welded, so this item can not be used.Did not occur during surgery so no surgeon was involved.This has been reported by one of the healthcare workers at the hospital who is the contact in this form.
Additional 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: d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h3.
Additional Manufacturer Narrative
Product complaint # : pc-(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 : 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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: update 19-april-2021, the investigation was re-opened upon receipt of the device.Examination of the returned device could not confirm the reported event.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: 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) where the lot code was provided.A manufacturing records evaluation (mre) was not performed.

• Brand Name: EXTERNAL ALIGN ANKLE CLAMP
• Common Device Name: KNEE INSTRUMENT : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11315742
• Report Number: 1818910-2021-02830
• Device Sequence Number: 2712976
• Product Code: HXD
• UDI-Device Identifier: 10603295125891
• UDI-Public: 10603295125891
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/05/2021

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
• Operator of Device: Health Professional
• Device Model Number: 2490-49-000
• Device Catalogue Number: 249049000
• Device Lot Number: SO2033673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 04/12/2021; 04/05/2021; 04/22/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 04/13/2021; 04/19/2021; 04/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1