MAUDE Adverse Event Report: SYNTHES MONUMENT STARDRIVE SCREWDRIVER T25 WITH T-HANDLE; SCREWDRIVERS

Catalog Number 03.620.001

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 05/20/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).Device is an instrument and is not implanted/explanted.Complainant device is not expected to be returned for manufacturer review/investigation.(b)(6).A device history record (dhr) review was performed for part #03.620.001, synthes lot#7875471: release to warehouse date: 02-feb-2015, expiration date: n/a, supplier: (b)(4): no non conformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.Patient code (b)(4) is used as the complainant indicated that the device fell apart and was not usable during the explant procedure.The surgery was not successfully completed.The implant was left in the patient.According to the provided picture it is confirmed that the handle has come off from the screwdriver shaft ¿ the screwdriver is not broken as mentioned on the device report.Part was not returned, an investigation could not be performed.A review of the device history records found no issues that would have contributed to this complaint.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the screwdriver was used for an extraction surgery on (b)(6) 2017.When surgeon turned the cable counterclockwise, the green part began to unscrew and release.No surgical delay was reported.Patient outcome is good.The doctor had placed the straight bar, without molding.When he wanted to unlock the system for correction, it failed.The green t-key was running false.The green part where it holds the key was spinning, completely free of the active tip.According to the surgeons the patient may have problems.It is not known what problems they expect.The surgery was not successfully performed.The implant was left in the patient.Concomitant device reported: straight bar (part # unknown, lot # unknown, quantity 1) this report is for one (1) stardrive screwdriver t25 with t-handle this is report 2 of 2 for complaint (b)(4).

Manufacturer Narrative

(b)(6).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 Description

Straight bar is the 6.0mm rod implanted in patient on (b)(6) 2017.Concomitant device reported: rod (498.151, lot number unknown, quantity 1).

Manufacturer Narrative

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.

• Brand Name: STARDRIVE SCREWDRIVER T25 WITH T-HANDLE
• Type of Device: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6733510
• MDR Text Key: 80701718
• Report Number: 1719045-2017-10672
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 07611819824041
• UDI-Public: (01)07611819824041(10)7875471
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.620.001
• Device Lot Number: 7875471
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: STRAIGHT BAR (PART # UNKNOWN, LOT # UNKNOWN, QTY 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 62