MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 56MM GRIPPER; HIP INSTRUMENTS : INSERTION DEVICES

Model Number	2218-90-056
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2021
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
It was reported that the product has worn out.
Event or Problem Description
Additional information received confirmed that the handle would not disengage.
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: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
1.What is go inventory? a tool that enables me to manage request & view both product & inventory within my accounts & across the depuy synthes product range.2.If she was aware of the broken instruments at the time they were entered into "go inventory" in the month of (b)(6), or if a non-j&j employee entered that information, and the sales specialist became aware of the product malfunctions only later when she submitted her complaint information on (b)(6) 2021.I am assuming when you use the term ¿she¿ you are referring to me & not the customer? if you are referring in the context to me i am a ¿male¿ it was report directly after the customer reported the product as damaged in april.The complaint was not submitted on the (b)(6) 2021.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided.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 review: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: PINNACLE 56MM GRIPPER
• Common Device Name: HIP INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12231658
• Report Number: 1818910-2021-16100
• Device Sequence Number: 3036385
• Product Code: HXC
• UDI-Device Identifier: 10603295102304
• UDI-Public: 10603295102304
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 07/08/2021

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: 2218-90-056
• Device Catalogue Number: 221890056
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 07/22/2021; 08/16/2021; 10/06/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 08/09/2021; 08/24/2021; 10/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1