MAUDE Adverse Event Report: SYNTHES GMBH RIA 2 BONE HARVESTING KIT 520MM STERILE; REAMER

Catalog Number 03.404.000S

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/25/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional product code: hrx.Complainant part is not expected to be returned for manufacturer review/ investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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.Device history lot: part #: 03.404.000s.Lot #: 88p5865.Manufacturing site: (b)(4).Supplier: synthes usa hq, inc.Release to warehouse date: feb 5, 2021.Expiration date: feb 01, 2022.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent for a surgery.While using the ria 2 with reamer head, while they removed the driver shaft and silicone tubing, the silicone tubing was torn.The surgery did not go through well and the patient outcome was unknown.Concomitant device reported: unk - reamers: reamer head: trauma (part# unknown; lot# unknown; quantity: 1).This complaint involves (1) device.This report is for (1) ria 2 bone harvesting kit 520mm sterile.This report is 1 of 1 for (b)(4).

• Brand Name: RIA 2 BONE HARVESTING KIT 520MM STERILE
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12521504
• MDR Text Key: 273092692
• Report Number: 8030965-2021-07957
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K111437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2022
• Device Catalogue Number: 03.404.000S
• Device Lot Number: 88P5865
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - REAMERS: REAMER HEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR