MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN ESC LINER EXTRACTOR TIP; HIP INSTRUMENTS : EXTRACTION INSTRUMENTS

Catalog Number 221800010

Device Problems Break (1069); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # b)(4).Investigation summary
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> examination of the returned instrument confirmed the complaint.The root cause is attributed to inadvertent use error.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.B)(4).Reports that central sterile at memorial has a cup extractor tip that is broken.I do not have broken tip piece but do have the rest of the extractor to return.This did not delay surgery.Examination of the returned instrument confirmed the tip broke off.A search of the complaint database by product code found similar complaints that were attributed to misuse.The instrument may have been used to pry out either a metal or ceramic liner instead of tapping to gently breaking the bond between the tapers.Review of the as400 found b)(4) of this lot were placed into distribution on b)(4) 2018.A search of the complaint database found no prior reports for this part and lot number combination.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the investigation, the need for corrective action is not indicated.Complaints will be monitored under post market surveillance b)(4).If information is obtained that was not available for the initial 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.

Event Description

It was reported that the central sterile has a cup extractor tip that is broken.I do not have broken tip piece but do have the rest of the extractor to return.This did not delay surgery.No one was injured.I can not fully read lot number, but am returning item.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary : examination of the returned instrument confirmed the complaint.The root cause is attributed to inadvertent use error.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINN ESC LINER EXTRACTOR TIP
• Type of Device: HIP INSTRUMENTS : EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• MDR Report Key: 9168819
• MDR Text Key: 184390298
• Report Number: 1818910-2019-108470
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295099505
• UDI-Public: 10603295099505
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 09/17/2019

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 Catalogue Number: 221800010
• Device Lot Number: NW218829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Initial Date Manufacturer Received: 09/17/2019
• Initial Date FDA Received: 10/08/2019
• Supplement Dates Manufacturer Received: 11/13/2019; 12/30/2019
• Supplement Dates FDA Received: 11/13/2019; 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1