MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PWR ADAPTOR-HALL/JACOBS; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number 71119012

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/03/2020

Event Type  Injury  

Event Description

It was reported during procedure the adapter won¿t capture drill or driver.The procedure was completed without delay.The surgery was completed with a competitor device.Patient injuries were not reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Investigation results: the device, used in treatment was returned for evaluation.Visual inspection of the returned device confirms that the device has signs of wear and tear from use.Functional testing of the returned device confirms that the returned device wouldn't capture driver with grip.The device was manufactured in 2008.According to clinical/medical investigation, complaint reports that the adapter won¿t capture drill or driver.Per complaint details, this occurred "during setup or inspection." the procedure was completed with a competitor device, without delay.No patient injury, or other complications were reported.Since no patient harm is being alleged, no further assessment is warranted at this time.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: PWR ADAPTOR-HALL/JACOBS
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10317803
• MDR Text Key: 200185274
• Report Number: 1020279-2020-03466
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 03596010409331
• UDI-Public: 03596010409331
• Combination Product (y/n): N
• PMA/PMN Number: K121714
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71119012
• Device Catalogue Number: 71119012
• Device Lot Number: 08EM14498
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/03/2020
• Initial Date FDA Received: 07/23/2020
• Supplement Dates Manufacturer Received: 04/01/2021
• Supplement Dates FDA Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention