MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP TI UNI SCREW 7MM X 40MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179788740
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	07/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.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 the screw heads got disassembled from the screw shaft ( 2 x 1797-88-740).The screws were implanted as per regular process.However, when the surgeon came to adjust the screw with the "head turner" instrument, the heads of the screws came loose.The surgeon had to remove the screws using the standard screwdriver and replaced them with new screws.Replacement screws will be needed - no charge po will be submitted shortly.Patient consequence?: no.Action taken for procedure:replaced with new screws.Is the information being submitted for this complaint all the details that are known/available regarding this event?: yes.
Additional Manufacturer Narrative
Product complaint #: (b)(4).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.Visual examination found that the tulip head¿s inner cap (saddle) had been raised and dislodged 45 degrees from its intended location.The edges of the saddle were bent, consistent with rod being forced into tulip¿s head with the dislodged saddle.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.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.The root cause cannot be positively determined from the information provided.However, a potential root cause may likely be that the inner cap was subjected to a higher than anticipated load resulting in the inner cap becoming dislodged from its intended location.The edges of the saddle were bent, consistent with rod being forced into the tulip's head with the dislodged saddle.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: EXP TI UNI SCREW 7MM X 40MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7753056
• Report Number: 1526439-2018-50740
• Device Sequence Number: 19291587
• Product Code: NKB
• UDI-Device Identifier: 10705034081564
• UDI-Public: (01)10705034081564
• Combination Product (Y/N): N
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2018

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: 179788740
• Device Catalogue Number: 179788740
• Device Lot Number: T4398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Initial Date Received by Manufacturer: 07/09/2018
• Supplement Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 08/06/2018
• Supplement Report FDA Received Date: 08/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1