MAUDE Adverse Event Report: STRYKER GMBH PIN TO ROD COUPLING HOFFMANN II COMPACT 5/3-4MM; COMPONENT, TRACTION, INVASIVE

Catalog Number 49401020

Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/03/2019

Event Type  malfunction  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

As reported: "during the operation, the needle clamp of hoffman ii product was not tightly clamped.After the nail is nailed, when connecting the pin rod chuck, it is found that the pin chuck is not clamped tightly and falls off after screwing.Subsequently, the operation was performed by other batch products." procedure was completed successfully with 15 minutes surgical delay and other batch of product was used to complete the surgery with no adverse consequences reported.

Event Description

As reported: "during the operation, the needle clamp of hoffman ii product [.] was not tightly clamped.After the nail is nailed, when connecting the pin rod chuck, it is found that the pin chuck is not clamped tightly and falls off after screwing.Subsequently, the operation was performed by other batch products." procedure was completed successfully with 15 minutes surgical delay and other batch of product was used to complete the surgery with no adverse consequences reported.

Manufacturer Narrative

The reported event could be confirmed.Inspection of the returned device showed that the pin to rod coupling is wrongly assembled.Based on investigation, the root cause was attributed to be manufacturing related.The failure was caused by a wrong assembly of the part.An nonconformity was raised to address the issue.If any further information is provided, the investigation report will be updated.

• Brand Name: PIN TO ROD COUPLING HOFFMANN II COMPACT 5/3-4MM
• Type of Device: COMPONENT, TRACTION, INVASIVE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9137836
• MDR Text Key: 193305588
• Report Number: 0008031020-2019-01338
• Device Sequence Number: 1
• Product Code: JEC
• UDI-Device Identifier: 07613327089158
• UDI-Public: 07613327089158
• Combination Product (y/n): N
• PMA/PMN Number: K102885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 01/08/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 49401020
• Device Lot Number: D30875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Initial Date Manufacturer Received: 09/03/2019
• Initial Date FDA Received: 09/30/2019
• Supplement Dates Manufacturer Received: 12/27/2019
• Supplement Dates FDA Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1