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

Model Number	232453
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Date of Event	08/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device [6l63316] number, and no non-conformances were identified.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported by the sales rep that during acl (anterior cruciate ligament) surgery on (b)(6) 2020, while passing 4.5 combo reamer, after it penetrated lateral cortex and lateral skin of the patient, it was discovered that the tip of the pin had broken off.An x-ray was called and a c-arm was used to obtain the broken piece.Another drill pin was inserted and surgery was completed successfully with no further harm to patient.There was a surgical delay of 20 to 30 minutes.No additional information was provided.
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 while passing 4.5 combo reamer, after it penetrating lateral cortex and lateral skin of patient, it was discovered that the tip of the pin had broken off.The complaint device is not being returned, it was retained by the customer, therefore unavailable for a physical evaluation.However, a photo was provided.Upon visual inspection of the photo, the device was broken in two pieces.The complaint reported was confirmed.The photo does not provide enough evidence to determine root cause.Hands on analysis should provide the evidence necessary to confirm the root cause.The possible root cause for the reported failure can be attributed to with excess force being applied in the device.However, this cannot be conclusive determined.  a manufacturing record evaluation was performed for the finished device [6l63316] 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: COMBO BEATH PIN EA
• Common Device Name: CANNULATED SURGICAL DRILL
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• MDR Report Key: 10507993
• Report Number: 1221934-2020-02432
• Device Sequence Number: 16912508
• Product Code: LXH
• UDI-Device Identifier: 10886705024544
• UDI-Public: 10886705024544
• Combination Product (Y/N): N
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 232453
• Device Catalogue Number: 232453
• Device Lot Number: 6L63316
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/20/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 29 YR