MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS TIB INSERT TRIAL MED 14MM; HIP INSTRUMENTS : TIBIAL TRIALS

Model Number	2987-22-314
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2021
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 insert has a smaller inner diameter than the trial post and cannot be attached to it.There was a five minute surgical delay.
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.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary : functional evaluation of the returned device confirmed the reported event.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 : a device history record (dhr) review was conducted by the manufacturing site.The dhr was received from iron mountain and reviewed by the supplier.100% inspection was performed on this insert trial (p/n (b)(6), lot bfi0e3v) batch using a pin gage for the 0.7188 bore hole.In addition to this inspection, a cmm scan was performed.The feature (0.7188 bore) is manufactured at op30.A review of the operation at op30, indicated that there were no parts scrapped related to this operation.Additionally, from this review, there was no indication of tooling change or any adjustment that occurred during the manufacturing process.

• Brand Name: LPS TIB INSERT TRIAL MED 14MM
• Common Device Name: HIP INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12273489
• Report Number: 1818910-2021-16938
• Device Sequence Number: 19983402
• Product Code: HWT
• UDI-Device Identifier: 10603295158479
• UDI-Public: 10603295158479
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 2987-22-314
• Device Catalogue Number: 298722314
• Device Lot Number: BFI0E3V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 08/19/2021; 10/12/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 09/01/2021; 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1