MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SHAFT; SCREWDRIVERS

Model Number	314.23
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device returned.A review of the device history record.Device history lot: part # 314.23.Synthes lot number: 4595501.Manufacturing site: synthes brandywine.Release to warehouse date: 10-nov-2003.No ncr¿s were generated during production.The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.Device history batch null, device history 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.Investigation summary background: it was reported on (b)(6) 2019, one (1) hex flexible screwdriver, one (1) hexagonal screwdriver shaft, and one (1) hexagonal screwdriver broke as mentioned by the sterile processing department (spd).There was no patient involvement.This complaint involves three (3) devices.Investigation flow: damage.Visual inspection: the cannulated 4.0 mm hexagonal screwdriver shaft (p/n 314.23, l/n 4595501) was returned and received at us cq.Upon visual inspected, it was observed it was cracked vertically in two spots along the distal edge of the driver.Rest of the device shows some scratches caused due to regular use which has no impact on the functionality of the device.Dimensional inspection: dimensional inspection of the received device was performed at cq.Document specification: review of the manufacturing record evaluation showed that there were no issues during the manufacture of this product, and any sub components, which would contribute to this complaint condition.The device received device is cracked but the reported condition cannot be confirmed.Hence confirming the allegation.Investigation conclusion: the complaint is confirmed but the reported condition of broken cannot be confirmed for the cannulated 4.0 mm hexagonal screwdriver shaft (p/n 314.23, l/n 4595501) as it was cracked on the distal edge of the driver.There was no indication that a design or manufacturing issue has caused the crack and hence the root cause cannot be determined.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 on (b)(6) 2019, one (1) hex flexible screwdriver, one (1) hexagonal screwdriver shaft, and one (1) hexagonal screwdriver broke and it was observed the distal tip of the cannulated 4.0 mm hexagonal screwdriver shaft is cracked as mentioned by the sterile processing department (spd).There was no patient involvement.This complaint involves three (3) devices.This report is for one (1) cannulated 4.0 mm hexagonal screwdriver shaft this report is 2 of 3 for (b)(4).

• Brand Name: CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SHAFT
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8871758
• Report Number: 2939274-2019-59569
• Device Sequence Number: 335111
• Product Code: HXX
• UDI-Device Identifier: 10886982188700
• UDI-Public: (01)10886982188700
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2019

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: 314.23
• Device Catalogue Number: 314.23
• Device Lot Number: 4595501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 08/07/2019
• Patient Sequence Number: 1