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

Model Number	210824
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	01/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).
Event or Problem Description
It was reported by the affiliate via online complaint submission tool that during a shoulder surgery the gryphon slotted sawtooth gde drill guide broke.The affiliate is awaiting, awaiting further details from account.Additional details provided by the affiliate reported no fragments were generated and a 10 minute surgical delay occurred.It was reported the patient did not suffer complications due to the surgical delay and the procedure was completed with another like device.The affiliate reported the device is available to be returned for evaluation.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary : according to the information provided, it was reported that during shoulder surgery the drill guide broken.The complaint device is not being returned, therefore unavailable for a physical evaluation.However, a photo was provided.Upon visual inspection of the photo, it was observed that the handle and the shaft of the device had been separated.The device is reusable.A visual observation revealed marks on the metal surface of the handle distal from the shaft connection point.Also, it was identified small indentations on the shaft slot nearest to the connection point to the handle.The photo provide evidence of the failure into device, therefore the complaint reported can be confirmed.As a result, we cannot determine a root cause for the reported failure, but the possible could be related to the broken weld failure could be due to the device being dropped/ mishandled on hard surface causing the weld to fail.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.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.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: according to the information provided, it was reported that during shoulder surgery the drill guide broken.The complaint device was received and evaluated, it was observed that the handle and the shaft of the device had been separated.The device is reusable.A visual observation revealed marks on the metal surface of the handle distal from the shaft connection point.Also, it was identified small indentations on the shaft slot nearest to the connection point to the handle.Therefore, the complaint reported can be confirmed.Upon further observation, the distal tip of teeth on the shaft seems to be slightly dented over.It was found the same findings as the photo provided by the customer.The possible root cause could be related when the device being dropped/ mishandled on hard surface causing the weld to fail.However, it cannot be conclusively affirmed.  a manufacturing record evaluation was performed for the finished device [1411001] 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.

• 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: 10442868
• Report Number: 1221934-2020-02284
• Device Sequence Number: 4092378
• Product Code: LXH
• UDI-Device Identifier: 10886705024063
• UDI-Public: 10886705024063
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2020

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: 1411001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2020
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 09/02/2020; 10/02/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 09/02/2020; 10/05/2020
• Patient Sequence Number: 1