MAUDE Adverse Event Report: SPINAL ELEMENTS, INC OVERWATCH; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	108-107-01-S
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During the review of dhr, it was concluded that the product was inspected and accepted for use and met all specified parameters of the quality inspection process (qip) with no associated nonconformance specific to this product issue.Returned device was visually inspected, functionally tested and the complaint was confirmed.The device tip is fracture off.The device otherwise meets dimensional specifications, except for the fractured tip.Root cause is unknown, but osteosclerotic bone and/or excessive force can result in device tip fracturing.
Event or Problem Description
While driving the pedicle bone screw, reportedly the driver tip fractured and remained in the head of the screw shank.Though the driver tip was identified, the surgeon elected to leave the driver tip and the screw in place.No injury to the patient was reported.

• Brand Name: OVERWATCH
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SPINAL ELEMENTS, INC; 3115 melrose drive, suite 200; carlsbad CA 92010
• MDR Report Key: 12619010
• Report Number: 3004893332-2021-00012
• Device Sequence Number: 4038697
• Product Code: LXH
• UDI-Device Identifier: 00840916134686
• UDI-Public: (01)00840916134686(10)200431(11)200805
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K161842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/12/2021

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: Health Professional
• Device Model Number: 108-107-01-S
• Device Catalogue Number: 108-107-01-S
• Device Lot Number: 200431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR