MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ZT TRIAL SLEEVE 18D SML; HIP INSTRUMENTS : FEMORAL TRIALS

Catalog Number	257618110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Implant date, explant date: device is an instrument and is not implanted/explanted.Investigation summary: no device associated with this report was received for examination.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.A complaint was received regarding an zt trial sleeve 18d sml stating: "while removing the srom sleeve in hard bone, it was damaged by sleeve removal instrument." the procedure was completed using an alternative instrument.An additional information request found: there was a small fragment that came off the sleeve trial.The lot number of the device is not known.A photograph of the device was provided.However, from the photo it cannot be confirmed if the device is damaged/shipped.The part was not returned to the company for investigation.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code was not provided.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Per the initial reporting; no additional investigative information will be provided.Investigational inputs were requested as indicated per internal procedures for this failure mode, however no information was provided to depuy.Without the physical complaint samples associated with this report, it was not possible to determine if the devices failed to meet specifications at the time it was released for distribution.  the devices associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.Overall, from the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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.
Event or Problem Description
Removing the srom sleeve in hard bone was damaged by sleeve removal instrument.Further clarification determined that there was a small fragment that came off the sleeve trial.

• Brand Name: ZT TRIAL SLEEVE 18D SML
• Common Device Name: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8449296
• Report Number: 1818910-2019-88375
• Device Sequence Number: 19586575
• Product Code: LXH
• UDI-Device Identifier: 10603295146605
• UDI-Public: 10603295146605
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/05/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 257618110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 03/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1