MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM FLEXIBLE SHAFT 620MM; REAMER

Model Number 352.044

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: investigation flow: damage.Visual inspection: the 5.0mm flexible shaft 620mm (p/n: 352.044, lot number: 24p7973) was received at us cq.Upon visual inspection, one of the tabs on the tip of the shaft was deformed.Additionally, scratches were observed on the shaft which were consistent with the field usage.No other issues were identified with the device.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection was performed due to post-manufacturing damage.Document/specification review: based on the date of manufacture the following drawing, reflecting the current and manufactured revision was reviewed.No design discrepancies were identified during the document review.Complaint confirmed? yes, the tip was deformed.Hence confirming the allegation.Investigation conclusion: this complaint is confirmed for 5.0mm flexible shaft 620mm (p/n: 352.044, lot number: 24p7973) as the tip was deformed.No definitive root cause could be determined based on the provided information.However, the deformation observed could have been a result of the device experiencing unintended forces.No new, unique, or different patient harms were identified as a result of this evaluation.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 history lot: part: 352.044, lot: 24p7973, manufacturing site: (b)(4), release to warehouse date: december 19, 2019.A manufacturing record evaluation was performed for the finished device part: 352.044, lot: 24p7973, and no non-conformance's were identified.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, during an unknown procedure, the threaded guide was not drilling to the guide.The surgeon used a different variable angle locking compression plate/12 hole/266mm/left.The tip of the flexible shaft and stardrive screwdriver shaft was bent and the medullary reamer head was broke inside the patient.The fragments from the device were broken in the patient, surgery was delayed roughly about twenty to thirty (20-30) minutes.The procedure was successfully completed.This complaint involves six (6) devices.This report is for (1) 5.0mm flexible shaft 620mm.This is report 1 of 1 for (b)(4).

• Brand Name: 5.0MM FLEXIBLE SHAFT 620MM
• Type of Device: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10711574
• MDR Text Key: 212299618
• Report Number: 2939274-2020-04745
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982194138
• UDI-Public: (01)10886982194138
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 352.044
• Device Catalogue Number: 352.044
• Device Lot Number: 24P7973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2020
• Date Device Manufactured: 12/19/2019
• 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