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

Model Number	232453
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).The lot number was unknown.Investigation summary: background: it was reported via complaint submission tool that during an arthroscopy acl repair the tip of the rigidloop 4.5mm combo reamer/passing pin out of the rigidloop adjustable disposables kit was broken.There was a surgical delay of 10 minutes.Fragments were generated and 2 x-rays were necessary.No patient consequence was reported.Investigation summary: the combo beath pin ea (part #: 232453, lot #: 2101002) was received and evaluated at us cq.Upon visual inspection, the 4.5 mm combo reamer tip of the device was broken and the broken piece was not returned.Hence, the reported condition can be confirmed as the alleged functional issue could be due to the observed condition.The possible root cause for the reported failure can be attributed to excessive force being applied to the device.However, this cannot be conclusively determined.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent to which this complaint is observed in the field.
Event or Problem Description
It was reported by the customer in (b)(6) that the combo beath pin device had an unspecified malfunction.During in-house engineering evaluation, it was determined that the tip on the device was broken.There was no procedure nor patient involvement reported.No additional information was provided.

• 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
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle CH-24-00 ; SZ CH-2400 ; 6013142063
• MDR Report Key: 12870461
• Report Number: 1221934-2021-03450
• Device Sequence Number: 20270979
• Product Code: HWE
• UDI-Device Identifier: 10886705024544
• UDI-Public: 10886705024544
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/24/2021

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 Model Number: 232453
• Device Catalogue Number: 232453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown