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

Catalog Number	49401020
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: COMPONENT, TRACTION, INVASIVE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9137836
• Report Number: 0008031020-2019-01338
• Device Sequence Number: 2282297
• Product Code: JEC
• UDI-Device Identifier: 07613327089158
• UDI-Public: 07613327089158
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K102885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 01/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1