MAUDE Adverse Event Report: STRYKER SPINE-FRANCE RELIANCE OSTEOTOME STRAIGHT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48360200
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/04/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device breaks at the slightest impact.This event occurred after one slap of the hammer.The case was completed using an alternative device.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment; results: the surgical technique for reliance indicates that intraoperative fracture or breakage of instruments can occur.Instruments which have experienced extensive use or extensive force are more susceptible to fracture.This device was less than 1 year old based on review of the manufacturing records.The stryker rep reported that the surgeon hit the instrument with a hammer and was reported to be brand new (not used) for the reported event.Conclusion: the plausible root cause of the reported event is likely extensive force applied to the instrument.
Event or Problem Description
It was reported that the device breaks at the slightest impact.This event occurred after one slap of the hammer.The case was completed using an alternative device.

• Brand Name: RELIANCE OSTEOTOME STRAIGHT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5610944
• Report Number: 0009617544-2016-00167
• Device Sequence Number: 1413
• Product Code: LXH
• UDI-Device Identifier: 07613327268362
• UDI-Public: (01)07613327268362
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 04/04/2016

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: 48360200
• Device Lot Number: 155421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2016
• Supplement Report FDA Received Date: 07/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1