MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS INSERTER EXTRACTOR; HIP INSTRUMENTS : EXTRACTION INSTRUMENTS

Model Number 2987-72-030

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/14/2021

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

It was reported that lps impactor/extractor bent while impacting the sleeve adapter into distal femur.No surgical delay.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary : examination of the returned device confirmed the bent condition.The investigation did not establish that a broader investigation or corrective action was necessary.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 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 product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: LPS INSERTER EXTRACTOR
• Type of Device: HIP INSTRUMENTS : EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12245758
• MDR Text Key: 264073512
• Report Number: 1818910-2021-16452
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295159131
• UDI-Public: 10603295159131
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/14/2021

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
• Device Operator: Health Professional
• Device Model Number: 2987-72-030
• Device Catalogue Number: 298772030
• Device Lot Number: SO2031554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Initial Date Manufacturer Received: 07/14/2021
• Initial Date FDA Received: 07/29/2021
• Supplement Dates Manufacturer Received: 08/17/2021
• Supplement Dates FDA Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1