MAUDE Adverse Event Report: SYNTHES GMBH UNK - DRILL BITS: SPINE; BIT,DRILL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: tatter, c.Et al (2022), fluoroscopy-assisted c1¿c2 posterior fixation for atlantoaxial instability: a single-center case series of 78 patients, medicina, vol.58 (114), pages 1-11 (sweden).This retrospective single-center consecutive cohort study aimed to evaluate and present our historical experience with non-navigated, fluoroscopy-assisted c1¿c2 posterior fixation for atlantoaxial instability, paying special attention to safety and outcomes.Between 2005 to 2019, a total of 78 patients who underwent posterior c1¿c2 fixation, using either trans-articular screws (tas) or screw-rod-construct (src), were included in the study.Median age at the time of surgery was 63 years (16¿83) and 46% (n=36) of the patients were male.Tas was performed in 26 patients, while src was performed in 52 patients.In src group, polyaxial screws (synapse, synthes, johnson & johnson, raynham, ma, usa), 3.5 mm in diameter, mostly 30 mm in length, were used.For c1 lateral mass screw insertion a custom-made drill and screw guide (synthes, johnson & johnson, raynham, ma, usa) was used.The median follow-up time was 6.8 years.The following complications were reported as follows: an unknown number of patients died.An unknown number of patients had motor deficit.An unknown number of patients had sensory deficit.An unknown number of patients had balance disorder.An unknown number of patients had bladder dysfunction.An unknown number of patients had pain: either experienced partial pain relief or no pain relief.An unknown number of patients had a tethered cord (discovered 6 years after surgery).An unknown number of patients had an unchanged frankel grade.An unknown number of patients had other adverse events: pneumonia, angioedema, superficial surgical site infection, bacteremia, non-st elevation myocardial infarction, and cerebral fat-embolism.An unknown number of patients with synthes had construct instability.Src group: 2 patients had intraoperative complications (vertebral artery injury).One occurred during c1-screw insertion and was treated with endovascular coiling.The other was a minor bleed during c2-drilling, but where angiography showed an intact lumen of the vessel and no additional treatment was needed.3 patients had screw malposition seen on postoperative ct-scan as follows: 1 lateral c1-screw with no bone purchase, 1 medial c1-screw breaching into the spinal canal, and 1 case where both c1-screws were considered inadequately positioned, with the latter two cases requiring revision surgery.1 case of extended posterior fixation due to renewed minor cervical trauma one year after surgery (src at index surgery); ct-scan showed resorption zones around the screws.1 patient had a sudden debut of neck pain 1 month after surgery, where a ct-scan showed a c2 screw migration on one side and the patient was revised with an extended posterior fixation.This report is for an unknown synthes spine drill bit.This report captures the reported event of intraoperative vertebral artery injury - minor bleed during c2-drilling, but where angiography showed an intact lumen of the vessel and no additional treatment was needed.A copy of the literature article is being submitted with this report.This is report 2 of 4 for (b)(4).

Manufacturer Narrative

Report is for an spine drill bit/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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: UNK - DRILL BITS: SPINE
• Type of Device: BIT,DRILL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 14307006
• MDR Text Key: 290960288
• Report Number: 8030965-2022-02970
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention