MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS; EXTRACTOR

Model Number 309.530

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: initial reporter is a synthes employee part 309.530, lot l774102: manufacturing site: haegendorf.Release to warehouse date: (b)(6) 2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.A product investigation was completed: upon visual inspection, it is noticed that the screw head got stuck on a non-synthes screw head; there were scratches on the tip of the screw.The remaining portions of the device show normal wear consistent with the repeated use of the device.Functional testing of the device cannot be performed as the tip of the device was stuck with another screw head and the extractor was received by itself.The complaint condition cannot be replicated with the returned device.Dimensional inspection cannot be performed due to post-manufacturing damage.The relevant drawings were reviewed; no design issues or discrepancies were found during this investigation.The complaint condition was confirmed as the device become inoperable since it was stuck in another screw head.No definitive root-cause can be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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 Description

It was reported that during a routine incoming inspection of a loaner set on an unknown date, the conical extraction screw for large screws & 4.9mm bolts was observed to be non-functional.There were no patient and surgical involvement reported.Upon visual inspection of the received device, it was noticed that the screw head got stuck on a non-synthes screw head; there were scratches on the tip of the screw.This report is for a conical extraction screw.This is report 1 of 1 for (b)(4).

• Brand Name: CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS
• Type of Device: EXTRACTOR
• 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11657953
• MDR Text Key: 245527276
• Report Number: 2939274-2021-01829
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10886982185846
• UDI-Public: (01)10886982185846
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 309.530
• Device Catalogue Number: 309.530
• Device Lot Number: L774102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1