MAUDE Adverse Event Report: PRECISION SPINE, INC. CUSTOM INSTRUMENT; PROBE

Catalog Number C2100

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/14/2022

Event Type  Injury  

Event Description

It was reported that during a procedure performed on (b)(6) 2022, the tip of the lenke probe broke off in the patient's pedicle while in use.The broken tip was left in the bone and a pedicle screw was successfully implanted.There was no delay to the procedure reported.

Manufacturer Narrative

Outcomes attributed to adverse event - other serious (important medical events) - retained foreign object.Occupation - other; distributor.Device evaluation - initial information provided indicates that the product is available but has not been returned to date.Without the opportunity to examine the product, no conclusions can be drawn as to the root cause of the malfunction.Review of device history records is not possible without lot information.Two-year complaint history review found this to be the only report for this part number.No corrective actions are recommended at this time.Should the product be received, a follow-up medwatch report will be filed upon completion of investigation.

Manufacturer Narrative

H3 device evaluation - fracture occurred approximately 4mm distal to the 10mm mark on the probe.The bent probes have experienced a bend with a permanent deflection approximately centered 4mm distal to the 10mm mark.Review of device history records found six (6) pieces of this lot released for distribution on 11/2/2017 with no deviation or anomalies.With distribution release dates of 4+ years, it is determined that root cause associated with the failure of this probe is that it has exceeded its usable life span due to normal wear and tear.As normal wear and tear is deemed responsible for instrument failure, no corrective action is warranted.

Event Description

It was reported that during a procedure performed on (b)(6) 2022, the tip of the lenke probe broke off in the patient's pedicle while in use.The broken tip was left in the bone and a pedicle screw was successfully implanted.There was no delay to the procedure reported.

• Brand Name: CUSTOM INSTRUMENT
• Type of Device: PROBE
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• Manufacturer (Section G): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• Manufacturer Contact: mike dawson ; 2050 executive dr; pearl, MS 39208 ; 6014204244
• MDR Report Key: 15183203
• MDR Text Key: 297496633
• Report Number: 3005739886-2022-00024
• Device Sequence Number: 1
• Product Code: HXB
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: C2100
• Device Lot Number: QC17236-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other