MAUDE Adverse Event Report: DEPUY SYNTHES SPINE MIS ALIGNMENT DEVICE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	279726400
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Reported by commercial coordinator in (b)(6).We have also product complaints in dc depuy (orthokit/loaner site) for 2017 year.Devices quarantined due to breakages, functional tests failures.In all cases no data available if any injures or adverse events.No information about surgery, delays, patient related data.
Additional Manufacturer Narrative
Visual examination of the returned device found the device tip was partially torn off.Device was submitted for fracture analysis.Optical imaging of the fractured tip on the alignment guide show deformation of the tip that would result from a cantilever load under axial compression.No material defects of other abnormalities were observed in this analysis.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.A trend analysis was conducted.No emerging trends were found requiring further actions.The root cause of the alignment device tip breaking cannot be determined from the samples and information provided.The results from fracture analysis have determined that a potential root cause may be unexpectedly high stresses placed on the driver tip during use, resulting in the tip breaking from a cantilever load under axial compression.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MIS ALIGNMENT DEVICE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6711837
• Report Number: 1526439-2017-10579
• Device Sequence Number: 2064504
• Product Code: LXH
• UDI-Device Identifier: 10705034199481
• UDI-Public: (01)10705034199481
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2017

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: Physician
• Device Model Number: 279726400
• Device Catalogue Number: 279726400
• Device Lot Number: GM3605403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Initial Date Received by Manufacturer: 07/10/2017
• Supplement Date Received by Manufacturer: 08/18/2017
• Initial Report FDA Received Date: 07/13/2017
• Supplement Report FDA Received Date: 08/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1