MAUDE Adverse Event Report: STRYKER SPINE-FRANCE RELIANCE TEARDROP CURETTE ANGLED; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number	48361630
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/15/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: "purpose of surgery: correction of kyphosis with vertebral body fracture.Procedure: screw and hook fixation: t9- iliac, decompression, plif: l2-s1, rod fixation.Two (2) cages were implanted in each vertebral space.The surgeon completed surgical incision closure after he took x-ray of frontal and sagittal.Before repositioning of the patient, the surgeon rechecked x-ray and found some particle.The surgeon open surgical incision again and removed the piece of the curette successfully.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment; results: the device was found to be manufactured almost 8 years ago.The general instruments ifu states that the life of the instrument depends on the number of times they are used as well as the precautions taken in handling, cleaning and storage.Great care must be taken of the instruments to ensure that they remain in good working order.Instruments should be examined for wear or damage by doctors and staff in operating centers prior to surgery.Conclusion: based on the age of the device and visual inspection, the probable root cause of this event is determined to be normal wear and tear of instruments.
Event or Problem Description
It was reported that: "purpose of surgery: correction of kyphosis with vertebral body fracture.Procedure: screw and hook fixation: t9- iliac.Decompression.Plif: l2-s1.Rod fixation.Cages were implanted in each vertebral space.The surgeon completed surgical incision closure after he took x-ray of frontal and sagittal.Before repositioning of the patient, the surgeon rechecked x-ray and found some particle.The surgeon open surgical incision again and removed the piece of the curette successfully.

• Brand Name: RELIANCE TEARDROP CURETTE ANGLED
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5869088
• Report Number: 0009617544-2016-00332
• Device Sequence Number: 16293124
• Product Code: LXH
• UDI-Device Identifier: 07613327269741
• UDI-Public: (01)07613327269741
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 48361630
• Device Lot Number: 049592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/11/2016
• Supplement Report FDA Received Date: 10/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 63