MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STARDRIVE SCREWDRIVER SHAFT T8 55MM; SCREWDRIVERS

Model Number 314.453

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device returned synthes rep.Investigation summary background: it was reported that on an unknown date, the star drive screwdriver shaft was found to be damaged on sims cabinet.There was no patient involvement.This complaint involves one (1) device.Investigation flow: damage.Visual inspection: the star drive screwdriver shaft t8 55 mm (p/n 314.453 lot 7528207) was received with a stripped, twisted, and rounded distal star drive tip.Additionally, the part/lot etching was faded and difficult to read.No other issues were identified with the returned components of the device.The driver showed potential end of life indicators and normal wear from consistent/heavy usage during visual inspection.Conclusion: after a visual inspection per guidance provided in windchill document # 0000277191, it is determined that the reusable instrument is worn from repeated use and servicing (7+ years); therefore, further investigation for the reported complaint device is not required.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.A review of the device history record: device history lot: part: 314.453.Lot: 7528207.Manufacturing site: (b)(4).Release to warehouse date: 30.September 2011.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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, the star drive screwdriver shaft was found to be damaged on sims cabinet.There was no patient involvement.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: STARDRIVE SCREWDRIVER SHAFT T8 55MM
• Type of Device: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8885896
• MDR Text Key: 154546631
• Report Number: 2939274-2019-59726
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10886982188854
• UDI-Public: (01)10886982188854
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 07/17/2019

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: 314.453
• Device Catalogue Number: 314.453
• Device Lot Number: 7528207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2019
• Initial Date FDA Received: 08/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2011
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1