MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 8.5MM/2.8MM WIRE SLEEVE MISC ORTHO SURGICAL INSTR

Model Number 312.08

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Reporter is a synthes employee. Part: 312. 08, lot: 3121840, manufacturing site: (b)(4), release to warehouse date: march 26 2009. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified. Visual inspection: the 8. 5mm/2. 8mm wire sleeve was received showing the teeth of the distal tip bent outwards. The tips/edges of the teeth are bent outwards. Due to the deformation, the wire sleeve may not securely sit into bone. Dimensional inspection: dimensional inspection of the distal tip could not be conducted due to post manufacturing damage. Document/specification review: the following drawings, reflecting the manufactured and current revision, were reviewed. 8. 5mm/2. 8mm wire sleeve. During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition. Conclusion: the complaint condition is confirmed for the 8. 5mm/2. 8mm wire sleeve as the tips/edges of the teeth are bent outwards. Due to the deformation, the wire sleeve may not securely sit into bone. No definitive root cause could be determined. It is possible that the wire sleeve encountered unintended/excessive forces, dense bone, and/or rough handling during device use. During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. 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 an unknown date, a wire sleeve from a headless compression screw loaner set was found to be unfit for surgical use during a routine inspection. There was no patient and procedure impact reported. Upon manufacturer receipt and investigation the device was found to be bend. This complaint involves one (1) 8. 5mm/2. 8mm wire sleeve. This report is 1 of 1 for (b)(4).

• Brand Name: 8.5MM/2.8MM WIRE SLEEVE
• Type of Device: MISC ORTHO SURGICAL INSTR
• 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9158396
• MDR Text Key: 196197906
• Report Number: 2939274-2019-61211
• Device Sequence Number: 1
• Product Code: LHX
• 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: 08/15/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 312.08
• Device Catalogue Number: 312.08
• Device Lot Number: 3121840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown