MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI SNAPON TRNSCT 47-62MM F/5.5/6.0MM ROD; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	04.633.347
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product codes: mnh, mni, kwq, kwp.Part 04.633.347-us, lot 84p1001: manufacturing date: december 30, 2020.Manufacturing site: (b)(4).A review of the device history record revealed no complaint related anomalies.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformance's noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the component device history record(s) determined the component lots met all specifications with no issues documented that would contribute to this complaint condition.A review of the raw material device history record(s) determined the raw material lots met all specifications with no issues documented that would contribute to this complaint condition.A product investigation was completed: visual inspection of the complaint device showed some cosmetic scratches but no other damage.No other issues were identified with the returned device.A functional test was performed on the returned device.Both the components were not able to be assembled as the translation screw was stuck in the t-rod and was not able to unscrew from the part, which would have caused a device interaction issue.The relevant drawing was reviewed.No dimensional inspection was performed since the complaint-relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.The complaint is confirmed.No definitive root cause can be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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 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 (b)(6) 2021, during a l2-pelvis transforaminal lumbar interbody fusion, the final tightening shaft for the matrix construct was slipping.Inspection of the tip looks like it is stripped.Alternate short shaft was used with minimal delay.Also the middle cap of the #7 cross link was not able to tighten down; a different #7 cross link was used with minimal delay.There were fragments generated and removed easily without additional intervention.The surgery was delayed for two (2) minutes and the procedure was successfully completed.During investigation of the returned devices, it was noted both the components were not able to be assembled as the translation screw was stuck in the t-rod and was not able to unscrew from the part, which would have caused a device interaction issue.This is report 2 of 2 for (b)(4).

• Brand Name: TI SNAPON TRNSCT 47-62MM F/5.5/6.0MM ROD
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11686051
• Report Number: 2939274-2021-01921
• Device Sequence Number: 19586998
• Product Code: NKB
• UDI-Device Identifier: 10705034746678
• UDI-Public: (01)10705034746678
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K100952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2021

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: 04.633.347
• Device Catalogue Number: 04.633.347
• Device Lot Number: 84P1001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 04/19/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MATRIX LOCKING CAP WITHOUT SADDLE; STRAIGHT TIP T25 DRIVER-LONG
• Patient Age: 67 YR
• Patient Weight: 147