MAUDE Adverse Event Report: STRYKER SPINE-US AERO AL INSERTER GUIDE INNER SHAFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number	48921100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that doctor initially inserted implant on the inserter into the patient.The doctor was not satisfied with the placement of the interbody and was moving the implant on the inserter side to side to move it more medial.When he was doing this, the tip of the draw rod broke off into the implant.He was able to retrieve the draw rod and tip.The second draw rod was used to rengage the inserter on top of the implant and the procedure continued with no issues.No adverse consequences to patient or surgical delay is reported.
Additional Manufacturer Narrative
Method: visual inspection, product history review, complaint history review, nc/capa history review, labelling review, risk assessment result: the customer reported event was confirmed via visual analysis.The inner shaft was returned in 2 pieces with the threaded tip fractured off of the main shaft.There was some thread deformation, however this may have been caused during extraction of the fragment.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: capa was opened and the root cause identified in the capa was determined to be excessive cantilever loading.This capa is currently still open and further investigation and any future actions will be taken through the capa.
Event or Problem Description
It is reported that doctor initially inserted implant on the inserter into the patient.The doctor was not satisfied with the placement of the interbody and was moving the implant on the inserter side to side to move it more medial.When he was doing this, the tip of the draw rod broke off into the implant.He was able to retrieve the draw rod and tip.The second draw rod was used to reengage the inserter on top of the implant and the procedure continued with no issues.No adverse consequences to patient or surgical delay is reported.

• Brand Name: AERO AL INSERTER GUIDE INNER SHAFT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7598084
• Report Number: 0009617544-2018-00141
• Device Sequence Number: 1754570
• Product Code: LXH
• UDI-Device Identifier: 07613327273496
• UDI-Public: 07613327273496
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2018

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: 48921100
• Device Lot Number: 143459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1