MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL COMBO BEATH PIN EA; CANNULATED SURGICAL DRILL

Model Number	232453
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	11/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Udi: (b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/ or duplicated.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 by the affiliate in (b)(6) that the wire guide of the combo beath pin ea device was ruptured.The procedure was completed using another wire with a 20 minute delay.There was a delay in the surgical procedure.There was a spare device available for use to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.Udi: (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.H10 additional narrative: investigation summary = > according to the information provided, it was reported a rupture of the wire guide during the procedure.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.However photos were provided.Upon visual inspection of the photos, the device was observed broken and fully separated.The reported complaint was confirmed.The photos does not provide enough evidence to determine root cause.A possible root cause can be associated to an excessive force applied during use, however it cannot be conclusively affirmed.Hands on analysis should provide the evidence necessary to confirm the root cause.A manufacturing record evaluation was performed for the finished device [3l39743] 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.Device history lot = > a manufacturing record evaluation was performed for the finished device [3l39743] number, and no non-conformances were identified.

• Brand Name: COMBO BEATH PIN EA
• Common Device Name: CANNULATED SURGICAL DRILL
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9370793
• Report Number: 1221934-2019-59763
• Device Sequence Number: 2902384
• Product Code: HWE
• UDI-Device Identifier: 10886705024544
• UDI-Public: 10886705024544
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2019

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: 02/28/2022
• Device Model Number: 232453
• Device Catalogue Number: 232453
• Device Lot Number: 3L39743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 11/21/2019; 01/27/2020
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 12/20/2019; 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1