MAUDE Adverse Event Report: SMITH AND NEPHEW INC OFFSET BROACH HANDLE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	71364023
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a malfunction in which the screws were slipping on the device.It was required to retrieve a plastic piece from the inside out of patient.
Additional Manufacturer Narrative
The associated offset broach handle was not returned for evaluation.Therefore a product analysis could not be performed.As the device information was not provided, the device history record review cannot be completed.Complaint history review could not be performed with any accuracy due to lack of batch information.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.Without the return of the actual product involved, 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: OFFSET BROACH HANDLE
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): SMITH AND NEPHEW INC; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7850921
• Report Number: 1020279-2018-01728
• Device Sequence Number: 2120023
• Product Code: MDM
• UDI-Device Identifier: 03596010479136
• UDI-Public: 03596010479136
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2019

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: 71364023
• Device Lot Number: 10JUC0005A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 01/29/2019; 01/29/2019
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 02/06/2019; 09/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CAT 71364023 LOT 03EM03928; CAT 71364023 LOT 10JUC0005A (X2); CAT 71364023 LOT 12KM06509; CAT 71364023 LOT 16JM02577