MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-LONG; SCREWDRIVERS

Catalog Number	03.632.074
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient involvement.Date of event: it is unknown when the event occurred.Device is an instrument and is not implanted/explanted.Product investigation is not yet completed; no conclusion could be drawn.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 upon routine inspection of field equipment two t-handles were found with the green handle becoming loose/un-threading from the metal shaft.No patient involvement.This complaint involves two (2) devices.This report is for a t-handle.This report is 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.The returned driver was examined and the complaint condition was unable to be confirmed as the handle/device shaft connection was found to be secure with no signs of loosening.As the complaint condition was unable to be replicated or confirmed and no defects or deficiencies were identified with the returned device which may have contributed to the complaint condition, the complaint related to this device is unconfirmed.

• Brand Name: T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-LONG
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE: SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7168630
• Report Number: 2939274-2018-50089
• Device Sequence Number: 1823650
• Product Code: HXX
• UDI-Device Identifier: 10705034719184
• UDI-Public: (01)10705034719184(10)7901815
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2017

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: Health Professional
• Device Catalogue Number: 03.632.074
• Device Lot Number: 7901815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 12/06/2017
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 01/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1