MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SCREWDRIVER, HEXAGONAL, SMALL, WITH HOLDING SLEEVE

Model Number 314.02

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device history lot.Part: 314.02.Lot: 240.Part/lot combination unknown at synthes (b)(4), therefore no mre possible.Device was manufactured before erp system was introduced in the year 1999.The device was received and a investigation summary was performed.Background: updated event description: it was reported that on an unknown date, the service and repair received a complaint from customer that a screwdriver hexagonal was not working properly due to the handle was broken in many pieces and screwdriver tip was worn.It is unknown where the issue was discovered.It is unknown if there was patient involvement.This complaint involves one (1) device.Us customer quality investigation flow: broken visual inspection: visual inspection of the returned device performed at customer quality (cq) confirmed the condition of handle breakage, which agrees with the reported complaint condition.The handle was received in two pieces separate from the metallic shaft and dowel pin.Additionally, both ends of the dowel pin are bent distally which suggests that the proximal end of the handle experienced blunt force such as hammer impact.It was also observed that the holding sleeve component is missing (was not returned) on the complaint device (part# 314.02 small hex screwdriver with holding sleeve).Dhr review: part/lot combination unknown at synthes (b)(4), therefore no mre possible.Device was manufactured before erp system was introduced in the year 1999.Document/specification review: the following design drawing were reviewed during this investigation: top level assembly design drawing 314_02.Handle component drawing.Dowel pin component tabulated design drawing es0003 revisions a-f.Shaft component drawing 314_02_1.The small hexagonal screwdriver with holding sleeve [314.02(0)] is a common reusable trauma instrument, noted in multiple system technique guides including: small fragment.In each system the driver is utilized to insert screws with 2.5mm hexagonal recesses.No product design issues or discrepancies were observed during this investigation.The hex tip is deformed/worn and therefore an accurate measurement could not be achieved at cq.Material analysis: the design specified the handle to be manufactured from phenolic le grade linen material.A material confirmation from the time of manufacture could not be reviewed due to the age of the device (over 19 years old).As the returned device is older that 19 years old, there is no indication that material properties contributed to the handle breaking.Investigation conclusion: a definitive assignable root cause for the handle breaking could not be determined based on the provided information.Both ends of the dowel pin are bent distally which suggests that the proximal end of the handle experienced blunt force such as hammer impact.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified as a result of this evaluation.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

Device report from synthes reports an event in (b)(6) as follows:it was reported that on an unknown date, the service and repair received a complaint from customer that a screwdriver hexagonal was not working properly.It is unknown where the issue was discovered.It is unknown if there was patient involvement.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: SCREWDRIVER, HEXAGONAL, SMALL, WITH HOLDING SLEEVE
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES HAEGENDORF GMBH-CN; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8476438
• MDR Text Key: 140909770
• Report Number: 2939274-2019-57231
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10886982188373
• UDI-Public: (01)10886982188373
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2019

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: 314.02
• Device Catalogue Number: 314.02
• Device Lot Number: 240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Initial Date Manufacturer Received: 03/11/2019
• Initial Date FDA Received: 04/02/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1