MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC AWL 2.5 W/SLEEVE W/VARIAB-ANG; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL

Model Number	03.647.994
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is jnj representative.Investigation summary: investigation flow: damage.Visual inspection: the awl 2.5 w/sleeve w/variab-ang (p/n: 03.647.994, lot number: 1l95347) was received at us cq.Visual inspection of the complaint device showed the tip of the device had broken off.Device failure/defect identified? yes.Dimensional inspection: a dimensional inspection was not performed due to post-manufacturing damage.Document/specification review: no design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the tip of the device had broken off.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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: 03.647.994.Lot: 1l95347.Manufacturing site: (b)(4).Release to warehouse date: dec.19, 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances 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 or Problem Description
Device report from (b)(6) reports an event as follows: it was reported on an unknown date that during the inspection of 2.5 awl, it was discovered the spring sleeve wouldn't thread properly, and was damaged when trying to re-engage into the sleeve.There was no patient consequences, or surgical delay involved.This complaint involves one(1) device.This report is for (1) mmsi driver shaft for red screw.This is report 1 of 1 for (b)(4).

• Brand Name: AWL 2.5 W/SLEEVE W/VARIAB-ANG
• Common Device Name: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10684479
• Report Number: 2939274-2020-04682
• Device Sequence Number: 14315212
• Product Code: OVE
• UDI-Device Identifier: 10705034720876
• UDI-Public: (01)10705034720876
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K112068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2020

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: 03.647.994
• Device Catalogue Number: 03.647.994
• Device Lot Number: 1L95347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 10/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1