MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STARDRIVE SCREWDRIVER SHAFT T8 105MM; SCREWDRIVERS

Model Number 314.467

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional 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.Investigation summary: complaint summary: flow: damage, visual inspection: the stardrive screwdriver shaft t8 105 mm (part # 314.467, lot # 7736541, mfg # 27-aug-2014) was received at us customer quality (cq) with was received showing the distal driver tip slightly twisted.This is consistent with the reported complaint condition, thus confirming the complaint.Conclusion: after a visual inspection per guidance provided in windchill document, it is determined that the reusable instrument is worn from repeated use and servicing.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.Device history lot: part # 314.467.Synthes lot # 7736541.Supplier lot # na.Release to warehouse date: 27 aug 2014.Manufactured by synthes monument.No ncr's were generated during production.Device history batch: null device history review: 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.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, during routine incoming inspection of loaner set it was observed that the stardrive screwdriver shaft was damaged.There was no patient involvement.This report is 1 of 1 (b)(4).

• Brand Name: STARDRIVE SCREWDRIVER SHAFT T8 105MM
• 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 ; 1101 synthes avenue; monument, CO 80132 ; 6103142063
• MDR Report Key: 9158796
• MDR Text Key: 191897973
• Report Number: 2939274-2019-61147
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10886982188922
• UDI-Public: (01)10886982188922
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152239
• 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: 09/09/2019

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: 314.467
• Device Catalogue Number: 314.467
• Device Lot Number: 7736541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Initial Date Manufacturer Received: 09/09/2019
• Initial Date FDA Received: 10/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1