MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRIAL SPACER 12/14 +10; HIP INSTRUMENTS : FEMORAL TRIALS

Model Number	2038-22-000
Medical Device Problem Codes	Break (1069); Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 it was noticed that the locking ring on trial taper spacer had been removed rendering instrument useless.No surgical delay.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.Depuy-synthes 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.Territory 234 reported that it was noticed that the locking ring on trial taper spacer had been removed rendering instrument useless.No surgical delay.Examination of the returned instrument confirmed the complaint of missing locking ring.Visual analysis found the trial spacer to be in good condition otherwise.The complaint sample consisted of (1) (b)(4) trial spacer 12/14 +10.A review of complaint database did not identify any other similar complaints received and the root cause cannot be determined.Based on the investigation, the need for corrective action is not indicated.Complaints will be monitored under (b)(4) post market surveillance.
Additional 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.Depuy-synthes 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # : (b)(4).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.

• Brand Name: TRIAL SPACER 12/14 +10
• Common Device Name: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9853521
• Report Number: 1818910-2020-08615
• Device Sequence Number: 11481680
• Product Code: LXH
• UDI-Device Identifier: 10603295084358
• UDI-Public: 10603295084358
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/04/2020

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: 2038-22-000
• Device Catalogue Number: 203822000
• Device Lot Number: HT0809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 03/23/2020; 04/02/2020; 04/02/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 03/31/2020; 04/13/2020; 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1