MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MTX CEM CUP P HEAD 32MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	MT2232
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery damaged impactor was noticed right before it was to be used.Cup was placed by hand.No backup device was available so procedure delayed more than 30 minutes.
Additional Manufacturer Narrative
The affected matrix cemented cup placement head was not returned for evaluation, therefore a product analysis could not be performed.After repeated requests, smith and nephew has been unable to obtain a batch number.A device history record cannot be completed.Complaint history review could not be performed with any accuracy due to lack of batch information.Without the return of the actual product involved and no batch information available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.

• Brand Name: MTX CEM CUP P HEAD 32MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8604530
• Report Number: 1020279-2019-01899
• Device Sequence Number: 2359058
• Product Code: LXH
• UDI-Device Identifier: 03596010012333
• UDI-Public: 03596010012333
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2019

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: MT2232
• Initial Date Received by Manufacturer: 04/22/2019
• Supplement Date Received by Manufacturer: 04/22/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 10/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1