MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL RETROREAMER (6-12MM); CANNULATED SURGICAL DRILL, SINGLE-USE

Model Number	232000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Unspecified Tissue Injury (4559)
Type of Reportable Event	Serious Injury
Event or Problem Description
This report is being filed after the review of a clinical study report: evaluation of healthcare outcomes of patients undergoing arthroscopic acl reconstruction using depuy synthes acl disposables kit or twistr¿ retrograde reamer.Soft tissue injury and infection had been identified as the reported complication as per icd 9 & 10 categorization experienced by the following with corresponding intervention: twistr retrograde reamer prod.# (b)(4).2 unknown patients required revision surgery within 90 days of their primary procedure.
Additional Manufacturer Narrative
(510k): this report is for an unknown implant.Part and lot number are unknown.Without the specific part number; the udi number, 510-k number and manufacturing site name are unknown.The lot number was unknown; therefore, the expiration date and manufacture date were unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Device evaluated by mfr: without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Investigation summary: the complaint device is not being returned, it was implanted in the patient, therefore unavailable for a physical evaluation.This complaint file was opened to document complaints derived through a journal article review.The journal article review indicated depuy (b)(4) product failure(s).It is unknown if complaints derived from this journal article were previously reported and documented in the depuy mitek complaint system at the time of occurrence as no product code/lot number information was provided to perform the search.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported problem.Since no lot number was provided, a manufacturing record evaluation or sterile load review could not be conducted.If any additional information is obtained, this complaint will be re-opened to capture that information.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes (b)(4) 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.

• Brand Name: RETROREAMER (6-12MM)
• Common Device Name: CANNULATED SURGICAL DRILL, SINGLE-USE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle CH-24-00 ; SZ CH-2400 ; 8472871282
• MDR Report Key: 14014523
• Report Number: 1221934-2022-01079
• Device Sequence Number: 6274482
• Product Code: HTO
• UDI-Device Identifier: 10886705025626
• UDI-Public: 10886705025626
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Study,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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?: No
• Operator of Device: Health Professional
• Device Model Number: 232000
• Device Catalogue Number: 232000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown