MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL GRYPHON SLOTTED SAWTOOTH GDE; BONENAIL GUIDEWIRE

Model Number	210824
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information provided, it was reported that during a shoulder arthroscopy the surgeon when taking out the drill the tip of the gryphon slotted sawtooth guide came out from the handle.The complaint device was received and inspected.It was observed that the handle and the shaft of the device had been separated.This complaint can be confirmed.The device is reusable.A visual inspection revealed that the device had been heavily used as striations on the metal surface of the handle distal from the shaft connection point.Also, it revealed small indentations on the shaft slot nearest to the connection point to the handle.The broken weld failure could be occurred during sterilization or that the device was dropped on hard surface causing the weld to fail.A manufacturing record evaluation was performed for the finished device [1310001] number, and no non-conformances were identified. at this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Udi:(b)(4).
Event or Problem Description
It was reported by the sales rep via phone that during a shoulder arthroscopy the surgeon when taking out the drill the tip of the gryphon slotted sawtooth guide came out from the handle.No fragments remained in the patient´s body.The procedure was completed using the same device.No patient consequences or surgical delay reported.The device is available to be returned for evaluation.

• Brand Name: GRYPHON SLOTTED SAWTOOTH GDE
• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10490311
• Report Number: 1221934-2020-02393
• Device Sequence Number: 3872886
• Product Code: LXH
• UDI-Device Identifier: 10886705024063
• UDI-Public: 10886705024063
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/14/2020

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: 210824
• Device Catalogue Number: 210824
• Device Lot Number: 1310001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 09/03/2020
• Patient Sequence Number: 1