MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.3MM CRUCIFORM SCREWDRIVER BLADE WITH HOLDING SLEEVE; SCREDRIVERS

Model Number	314.411.96
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device returned.Synthes rep.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.A review of the device history record has been requested.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 on an unknown date, during routine incoming inspection of a loaner set at fsl (b)(4) site, the cruciform screwdriver blade with holding sleeve was observed broken.There was no patient involvement.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.A review of the device history record.Device history lot provided lot number 3l16306 is not correct.Based on the pictures and the information in the erp system is the correct lot number 3l18306, therefore mre was made for this lot number: part: 314.441.96.Lot: 3l18306.Manufacturing site: haegendorf.Release to warehouse date: 25.Feb.2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.It was reported on an unknown date, during routine incoming inspection of a loaner set at fsl ups lyndhurst, nj site, the cruciform screwdriver blade with holding sleeve was observed broken.There was no patient involvement.This complaint involves one (1) device.Investigation flow: damage.Visual inspection: the 1.3mm cruciform screwdriver blade with holding sleeve (p/n 314.411.96 lot 3l18306) was received showing no visual defects or deformities on the sleeve or blade subcomponents.There were no fracture locations observed on the instrument.All subcomponents were received.Device is etched with product code 314.411 and lot number 3l18306.Lot number 3l18306 traces to product code 314.411.96 in our manufacturing records.The.96 suffix indicates that the device was sold by the trauma/cmf sales department.Product code 314.411 and 314.411.96 are identical in design.No device failure/defect was identified with the returned device.Conclusion: the complaint condition is unconfirmed for the 1.3mm cruciform screwdriver blade with holding sleeve (p/n 314.411.96 lot 3l18306) as the instrument was received showing no visual defects or deformities on the sleeve or blade subcomponents.All subcomponents were received.No definitive root cause for the reported complaint condition could be determined.The complaint is unconfirmed.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.

• Brand Name: 1.3MM CRUCIFORM SCREWDRIVER BLADE WITH HOLDING SLEEVE
• Common Device Name: SCREDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8871392
• Report Number: 2939274-2019-59566
• Device Sequence Number: 16271854
• Product Code: HXX
• UDI-Device Identifier: 10886982188809
• UDI-Public: (01)10886982188809
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2019

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
• Operator of Device: Health Professional
• Device Model Number: 314.411.96
• Device Catalogue Number: 314.411.96
• Device Lot Number: 3L18306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Initial Date Received by Manufacturer: 07/11/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 09/05/2019
• Patient Sequence Number: 1