MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF TRIAL SHELL HANDLE; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71362297
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that threads on the impactor are stripped.Implant is not able to be attached to the impactor.Delay over 30 minutes was reported.Device backup was available.
Additional Manufacturer Narrative
The associated complaint device was not returned.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, the complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: REF TRIAL SHELL HANDLE
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8881974
• Report Number: 1020279-2019-02998
• Device Sequence Number: 1903386
• Product Code: JDI
• UDI-Device Identifier: 03596010456540
• UDI-Public: 03596010456540
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2019

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: 71362297
• Device Lot Number: 08AM23695
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 08/11/2019
• Supplement Report FDA Received Date: 10/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1