MAUDE Adverse Event Report: SYNERGETICS, INC PINNACLE 360 INTRAOCULAR FOREIGN BODY MAGNET; OPHTHALMIC SOFT-TISSUE MANIPULATION FORCEPS, PROBE

Model Number	12.21PIN
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Though requests have been made, the device has not been returned.Lot m0013390 of 12.21pin, pinnacle foreign body magnet, consisted of 50 instruments that were 100% inspected by production and sampled by qc.The lot was released for sterilization on 16nov2017.The inspection of this instrument includes visual and dimensional evaluations, including a magnet strength test, an actuation test, a tip condition evaluation, a push test, and an assembly/workmanship evaluation where the nosecone resists disassembly when subjected to moderate rotational torque levels and the tail is subjected to moderate pull force.During the qc inspection of the 5-piece sample in the above assembly and workmanship evaluation, one (1) unit was found where the magnet came out of the tube during the inspection.The lot was rejected and reworked per existing work instructions.The lot was again subjected to another 5-pc sample inspection.The lot passed the inspection after production reworked the lot, and the lot was released.There were no deviations or red-lined drawings on lot m0013390.There have been no other complaints received on this product since 2018.There have been no other complaint reports on instruments from this lot.The investigation is ongoing.
Event or Problem Description
A user facility in (b)(6) reported that during contact with a foreign body, the magnetized part of the instrument became detached from the instrument and remained in contact with the foreign body.The instrument was removed from the eye without its tip, which remained in the intraocular space.The defective tip was then removed from the eye.No clinical consequences was reported.
Additional Manufacturer Narrative
The complaint was not able to be replicated since the part was not returned.The root cause is unknown/inconclusive.Should a sample become available, the complaint will be revisited.This discrepancy is being considered an anomaly based on a review of the dhr and the product field history.Quality engineering will continue to monitor and if an adverse trend is identified, then initiate appropriate action.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action is required.No patient impact/injury.Should the product be received, the investigation will be reopened.The investigation is considered complete at this time.
Additional Manufacturer Narrative
The device was returned for evaluation.The outer tube was removed so the inner tube with the glue joint could be observed.The glue joint appears to have given way which allowed the magnet to separate from the tube holder during use.The most probable root cause is manufacturing.A system enhancement is being explored to see if the joint between the magnet and the cutoff tube holder can be improved.The investigation is complete.

• Brand Name: PINNACLE 360 INTRAOCULAR FOREIGN BODY MAGNET
• Common Device Name: OPHTHALMIC SOFT-TISSUE MANIPULATION FORCEPS, PROBE
• Manufacturer (Section D): SYNERGETICS, INC; 3845 corporate center dr; o''fallon MO 63368
• MDR Report Key: 12332810
• Report Number: 0001932402-2021-00003
• Device Sequence Number: 14624416
• Product Code: MDM
• UDI-Device Identifier: 20841305108817
• UDI-Public: (01)20841305108817(10)M0013390
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/21/2021

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 Expiration Date: 11/02/2020
• Device Model Number: 12.21PIN
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 09/01/2021; 10/06/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 09/24/2021; 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1