MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PFC STEM TRIAL EXTRACT; HIP INSTRUMENTS : FEMORAL TRIALS

Catalog Number 865226

Device Problem Fracture (1260)

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

Event Date 06/27/2018

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

Product name: pfc stem trial extractor.Product code: 865226.Lot/batch/exp: tbc.Was the product being used in a clinical trial? no.Did the event happen during a procedure? yes.Were you in the procedure at the time of the event? yes.Event outcome/how was it managed? broken instrument removed using cold chisel and molegrips.Was there any consequence to the patient due to the event? was the surgery prolonged due to the event? if yes, confirm how many minutes delay ¿ surgery delay was approximately 20 minutes.Has the reporter facility indicated there may be legal action? no.Is the product available for return? yes after cleaning and decon.Please give a detailed explanation of the event: the operation was a distal femur to sleeve case.The surgeon has been using the kit for over 5 years and is a kol and visitation for us.After the trial the surgeon removed the trial components and, as if often the case, in these patients the 31mm sleeve trial and 20 x 115 stem trial disassociated from the trial distal femur.The surgeon inserted the stem trial extractor, attached the slap hammer and tried to remove the trial sleeve and stem.The end of the instrument shear off at the point where the screw thread starts creating a situation where there is no option but to open an additional set of instruments to get a pair of mole grips.

Manufacturer Narrative

Product complaint # pc-(b)(4).Investigation summary examination of the returned device confirmed the reported event.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessar.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.

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.

• Brand Name: PFC STEM TRIAL EXTRACT
• Type of Device: HIP INSTRUMENTS : FEMORAL TRIALS
• 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: 7717747
• MDR Text Key: 114945310
• Report Number: 1818910-2018-65134
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295216766
• UDI-Public: 10603295216766
• 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: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 865226
• Device Lot Number: TX6255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2012
• 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