MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC T-HANDLE BALL HEX SCREWDRIVER 8MM

Model Number	03.010.517
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: reporter is a synthes employee.Part: 03.010.517-us, lot: 9562292, manufacturing site: (b)(4), release to warehouse date: september 23, 2015.A manufacturing record evaluation was performed for the non-sterile device lot number, and no non-conformances were identified.Visual inspection: the t-handle ball hex screwdriver 8mm was received at us customer quality (cq).Visual inspection of the complaint device showed the shaft of the device was bent.Also, the hex ball tip was stripped which is consistent with the device use which would not contribute to the complaint condition.No other issues were observed with the complaint device.Dimensional inspection: feature: shaft diameter.Measured dimension: conforming.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the device was received with bent shaft.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 that on (b)(6) 2021, when the case was finished it was discovered that the t-handle ball/hex screwdriver had a small bend in the shaft.The case was already completed, and there was no patient impact.Upon manufacturer investigation, it was determined that the hex ball tip was stripped.This report is for a t-handle ball hex screwdriver 8mm.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Reporter is a synthes employee.Part: 03.010.517-us, lot: 9562292, manufacturing site: (b)(4), release to warehouse date: september 23, 2015.A manufacturing record evaluation was performed for the non-sterile device lot number, and no non-conformances were identified.Visual inspection: the t-handle ball hex screwdriver 8mm was received at us customer quality (cq).Visual inspection of the complaint device showed the shaft of the device was bent.Also, the hex ball tip was stripped which is consistent with the device use which would not contribute to the complaint condition.No other issues were observed with the complaint device.Dimensional inspection: feature: shaft diameter.Measured dimension: conforming.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the device was received with bent shaft.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 that on (b)(6) 2021, when the case was finished it was discovered that the t-handle ball/hex screwdriver had a small bend in the shaft.The case was already completed, and there was no patient impact.Upon manufacturer investigation, it was determined that the hex ball tip was stripped.This report is for a t-handle ball hex screwdriver 8mm.This is report 1 of 1 for (b)(4).

• Brand Name: T-HANDLE BALL HEX SCREWDRIVER 8MM
• Common Device Name: SCREWDRIVER
• 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13236631
• Report Number: 2939274-2022-00133
• Device Sequence Number: 4280724
• Product Code: HXX
• UDI-Device Identifier: 10886982069306
• UDI-Public: (01)10886982069306
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 03.010.517
• Device Catalogue Number: 03.010.517
• Device Lot Number: 9562292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown