MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 MODIFIED HUDSON ADAPTER; KNEE INSTRUMENT : ADAPTORS

Catalog Number 217863136

Device Problems Loose or Intermittent Connection (1371); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2018

Event Type  malfunction  

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

Product code : 217863136.Lot/batch/exp: unknown.Did the event happen during a procedure? yes.Were you in the procedure at the time of the event? yes.Was the product being used in a clinical trial? no.Event outcome/how was it managed? reamer removed with jacobs chuck.Was there a patient impact or was the procedure extended greater than 30 minutes due to the failure? less than 30 min delay.Impact: compromised reaming diameter.Surgery was completed ok.Has the reporter facility indicated there may be legal action? no.Is the product available for return? it will be once received from external sterile services.Please give a detailed explanation of the event: reamer was used with the t-handle and adaptor.Adapter started slipping / not gripping.This resulted in the reamer being stuck in the femur.Reamer removed with powertool and jacobs chuck.Surgeon could not perform further reaming as there were no other alternatives available.Surgeon judged that this would be sufficient to proceed.Surgery completed ok and in good time.

Manufacturer Narrative

Product complaint # pc-(b)(4).

Manufacturer Narrative

Product complaint # : (b)(4).The device was returned and confirmed it was worn.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.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MODIFIED HUDSON ADAPTER
• Type of Device: KNEE INSTRUMENT : ADAPTORS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7722220
• MDR Text Key: 115105923
• Report Number: 1818910-2018-65266
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 10603295096252
• UDI-Public: 10603295096252
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 217863136
• Device Lot Number: H0210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNK KNEE INSTRUMENT