MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC NAVIGABLE AWL-TAP 3.5MM DUAL CORE/6MM HXC; NEUROLOGICAL STEREOTAXIC INSTR

Model Number	03.632.220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information was not provided for reporting.Event date: unknown date in (b)(6) 2018.Additional device product code: olo.Device is an instrument and is not implanted / explanted.Reporter is synthes sales representative.The device was received, and the product evaluation is in progress.No conclusion can be drawn.Additionally, device history records review has been requested.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 that on an unknown date in (b)(6) 2018, patient underwent a spinal fusion procedure.During the surgery, a navigable awl-tap broke off.Surgeon was unable to extract tap from the patient pedicle.It is unknown if there was a surgical delay.Procedure and patient outcome were not reported.This report is for one (1) navigable awl-tap 3.5mm dual core/6mm hxc.This is report 1 of 6 for (b)(4).
Additional Manufacturer Narrative
Part: 03.632.220; lot: 9035785; manufacturing site: (b)(4); release to warehouse date: (b)(6) 2014.The device history record shows this lot of 19 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and xxxxx criteria at the time of release with no issues documented during the manufacturing process.Only the top level of the device history record was reviewed as the sub-components are not lot tracked, therefore a material/hardness review could not be performed.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.It was reported that during hole preparation of a spinal fusion procedure on (b)(6) 2018, a navigable awl-tap broke off.Surgeon was unable to extract tap from the patient pedicle.It is unknown if there was a surgical delay.Procedure and patient outcome are unknown.Flow: broken.Visual inspection: the navigable awl-tap, dual-core, 6 mm hex coupling (part # 03.632.220, lot # 9035785, mfg # 14-jul-2014) was received at us customer quality (cq) with the distal tip of the awl broken.The fracture site is at the point where the threaded portion of the distal tip starts.This agrees with the reported complaint condition, thus confirming the complaint.Medical images were not provided therefore the embedded condition cannot be confirmed by cq.Also, no fragments were returned to cq.Dimensional analysis was completed, the length of the proximal end of the stop to the distal tip of the awl, measured 164.02 mm (caliper ca472).This is not within specification of 210 mm ± 0.3, based on drawing since the distal tip broke off.Therefore, the broken portion of the distal tip is approximately 45.98 mm.Measurements close to the fracture site could not be obtained due to post-manufacturing damage.The relevant design drawings were reviewed.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Only the top level of the device history record was reviewed as the sub-components are not lot tracked, therefore a material/hardness review could not be performed.The complaint condition is confirmed as the awl (part # 03.632.220, lot # 9035785) was received with the distal tip broken.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.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.

• Brand Name: NAVIGABLE AWL-TAP 3.5MM DUAL CORE/6MM HXC
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7886702
• Report Number: 2939274-2018-53841
• Device Sequence Number: 2508563
• Product Code: HAW
• UDI-Device Identifier: 10705034719542
• UDI-Public: (01)10705034719542
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K122211
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.632.220
• Device Catalogue Number: 03.632.220
• Device Lot Number: 9035785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 09/18/2018
• Supplement Report FDA Received Date: 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention