MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 CANNULATED MODULAR TAP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48280185
Medical Device Problem Code	Residue After Decontamination (2325)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/21/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that they analysed what looked like debris on kits that had been returned from an external sterilisation provider and found both debris and rust.Following re-processing the customer found debris on the kits and after they repeated the wash and clean processes with ultrasonic pre clean, the sets still have debris on some instruments.The adverse incident recorded by the customer internally stated that 'trays opened for patients operation.Debris in cannulated taps and screw driver handle, therefore kit unusable.So instrument tray, taps and awl have debris in.Then kit 3 opened, debris in awl and cannulated taps.No other kit available in hospital.The fixation tray, hole in kit through all layers and debris therefore case cancelled.
Additional Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: no relevant manufacturing issues were identified.Inspection of the returned device did not reveal any identifiable debris or rust.Conclusion: because the reported issue was not observed in-house, the issue could not be fully investigated and a definite root cause could not be determined.However, it is likely that the extended time between use and cleaning identified contributed to the event.
Event or Problem Description
It was reported that they analysed what looked like debris on kits that had been returned from an external sterilisation provider and found both debris and rust.Following re-processing the customer found debris on the kits and after they repeated the wash and clean processes with ultrasonic pre clean, the sets still have debris on some instruments.The adverse incident recorded by the customer internally stated that 'trays opened for patients operation.Debris in cannulated taps and screw driver handle, therefore kit unusable.So instrument tray, taps and awl have debris in.Then kit 3 opened, debris in awl and cannulated taps.No other kit available in hospital.The fixation tray, hole in kit through all layers and debris therefore case cancelled.

• Brand Name: ES2 CANNULATED MODULAR TAP
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6523763
• Report Number: 0009617544-2017-00173
• Device Sequence Number: 1642982
• Product Code: LXH
• UDI-Device Identifier: 07613327003413
• UDI-Public: (01)07613327003413
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2017

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: No Information
• Device Catalogue Number: 48280185
• Device Lot Number: 151121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/31/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2017
• Supplement Report FDA Received Date: 06/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1