MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PIN TRL LNR NEUT 62ODX28ID; HIP INSTRUMENTS : ACETABULAR TRIALS

Model Number	2218-28-062
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2020
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
Staff have indicated that the mentioned liner trials have all been stripped and no longer properly work with the screwdriver for insertion or removal.The liner impactor handle has been cracked due to wear and tear and also needs replacing.Please send replacements as soon as possible.Did not occur intra-op and therefore no patient issues or surgical delay.No further information is available.Please send replacements direct to the following address: (b)(6).Patient status/ outcome / consequences: no.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.Is the patient part of a clinical study: unknown.Ip (b)(4).Device property of none, device in possession of none, ip (b)(4).Device property of none.Device in possession of none.Ip (b)(4).Device property of none.Device in possession of none.Ip (b)(4).Device property of none.Device in possession of none.Ip (b)(4).Device property of none.Device in possession of none.Ip (b)(4).Device property of none.Device in possession of none.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.True.
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.

• Brand Name: PIN TRL LNR NEUT 62ODX28ID
• Common Device Name: HIP INSTRUMENTS : ACETABULAR TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10323243
• Report Number: 1818910-2020-16867
• Device Sequence Number: 19561233
• Product Code: LXH
• UDI-Device Identifier: 10603295100263
• UDI-Public: 10603295100263
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2020

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: 2218-28-062
• Device Catalogue Number: 221828062
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2020
• Supplement Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1