MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 90 DEGREE SCREWDRIVER T-HANDLE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number SD03.505.005

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Reporter is company representative.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 (b)(6) 2020, an inventory check occurred and multiple devices including a mesh cutter, right angle bender, plate cutter, 90 degree screwdriver t-handle, handle for 90° screwdriver, shaft for 90° screwdriver, and matrixrib screwdriver blade self-retaining f/90° screwdriver were found with malfunctions.When tested, the devices would not work properly; would not turn, hold screws, and some were stripped.Some instruments were bent or dull.There was no patient or procedure involvement.(b)(4).

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6- visual inspection results part number: sd03.505.005 lot number: 9921206 product was received with one of the two pin components (sd03.505.005.05) heavily bent/deformed.The other pin was slightly deformed.A dent was observed on the chamfer of the 90 degree screwdriver body (sd03.505.005.01) near the location of the bent pin component.There was no evidence of physical device breakage so the reported condition of broken was not confirmed.The complaint condition of "deformed/bent" was confirmed, as it matches the reported condition, but upon further analysis it was determined not to be related to the manufacturing process for the following reason: the product passed all inspection criteria (100% visual and ctq features) and was found to be within specifications at the time it was released to the warehouse.The certificate of compliance from supplier isimac certifies that all product was manufactured in accordance with the product drawing and no nonconformance's related to the complaint condition were present for the complainant lot.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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 history lot part #: sd03.505.005 synthese lot #: 9921206 manufacturing site: synthese brandywine release to warehouse date: (b)(6) 2016 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.

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.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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: 90 DEGREE SCREWDRIVER T-HANDLE
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10581224
• MDR Text Key: 208385292
• Report Number: 2939274-2020-04314
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 10887587071671
• UDI-Public: (01)10887587071671
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SD03.505.005
• Device Catalogue Number: SD03.505.005
• Device Lot Number: A7GA27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Date Manufacturer Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1