MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC; SCREWDRIVERS

Model Number 03.130.010

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record.Device history lot: part #: 03.130.010.Synthes lot number: h659973.Manufacturing site: synthes monument.Release to warehouse date: 16-jan-2019.No ncr¿s were generated during production.Device history batch null, device history review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Investigation summary background: it was reported that on an unknown date, a stardrive screwdriver shaft was found out to be broken on top of sims cabinet.It is unknown if there were a procedure and patient involvement.This complaint involves one (1) device.Investigation flow: damage.Visual inspection: the stardrive screwdriver shaft/t4 50mm/self-retaining/hxc (p/n 03.130.010 lot h659973) was received showing a portion of the distal stardrive tip twisted.No other issues were identified with the returned components of the device.The device failure/defect of twisted tip was identified during the investigation.Dimensional inspection: the following drawings, reflecting the manufactured and current revision, were reviewed.Stardrive screwdriver shaft t4 03_130_010 rev d.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A review of the manufacturing record evaluations was performed for the finished device lot number, and no non-conformance's were identified.Conclusion: the complaint condition is confirmed for the stardrive screwdriver shaft/t4 50mm/self-retaining/hxc (p/n 03.130.010 lot h659973) as a portion of the distal stardrive tip was observed to be twisted.While no definitive root cause could be determined, it is possible that the excessive torque/force was used during screw insertion, resulting in the twisted tip.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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

It was reported that on an unknown date, a stardrive screwdriver shaft was discovered broken on top of the sims cabinet.It is unknown if there were a procedure and patient involvement.The allegation of this device is that the star part of the screwdriver was not capturing and holding screws as it was intended.It was also reported that the threads appeared to be damaged.This complaint involves one (1) device.This report is 2 of 2 for (b)(4).

• Brand Name: STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC
• Type of Device: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9219338
• MDR Text Key: 190336200
• Report Number: 2939274-2019-61689
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10886982075192
• UDI-Public: (01)10886982075192(
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/04/2019

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
• Device Operator: Health Professional
• Device Model Number: 03.130.010
• Device Catalogue Number: 03.130.010
• Device Lot Number: H659973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Initial Date Manufacturer Received: 10/04/2019
• Initial Date FDA Received: 10/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2019
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1