MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 4.0 PLY SCRW 3.5X16; PPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	1020-35-116S
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: additional device product code: nkg.Photo investigation: the photo was returned to depuy synthes for evaluation.Visual analysis of the photo revealed that the head of the 4.0 ply scrw 3.5x16, p/n: 102035116s, broke off.The investigation can not confirm that the broken fragments remain inside the body of the patient since no post-operative images were provided.No other problems identified.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for 4.0 ply scrw 3.5x16, p/n: 102035116s.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.Device was used for treatment, not diagnosis.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
It was reported that on an unknown date in 2022, the surgeon was in the process of placing his lateral mass screws for an occiput to c5 instrumented fusion.For his lateral mass screws, he used a midas drill to start his screw holes.He did this at c3, c4 and c5.Following this, he used fixed drill guides starting at 14 mm in length.He drilled at 14 mm depth, ball tipped, 16 mm depth, ball tipped, and then lastly, drilled at 18 mm depth.After ball tipping at 18 mm depth, he chose to place 3.5 x 16 mm symphony screws.While placing his left c5 lateral mass screw, the surgeon needed 1/2-1 more full revolution of the screw before he was happy with the placement.He had disengaged the symphony screw driver retaining sleeve.While still having the symphony driver shaft engaged into the recess of the screw, he attempted that 1/2 - full turn.Unfortunately, in doing so, the screw head had sheered off from the shank of the screw.Multiple removal techniques were attempted, but unfortunately, the shank of the screw was flush with the bone interface and was left with the patient.The surgery was not completed successfully with a surgical delay of thirty (30) minutes.Patient left surgery with a shank of screw still left in bone and not fused to the planned level that was established pre-operatively.This report is for one (1) 4.0 ply scrw 3.5x16.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 4.0 PLY SCRW 3.5X16
• Common Device Name: PPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 8472871282
• MDR Report Key: 15261210
• Report Number: 1526439-2022-01424
• Device Sequence Number: 20510951
• Product Code: KWP
• UDI-Device Identifier: 10705034524382
• UDI-Public: (01)10705034524382
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K192014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: Health Professional
• Device Model Number: 1020-35-116S
• Device Catalogue Number: 102035116S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown