MAUDE Adverse Event Report: SYNTHES GMBH 13.0MM REAMER HEAD FOR RIA 2 STERILE; ACCESSORIES, ARTHROSCOPIC

Catalog Number 03.404.022S

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 10/22/2020

Event Type  Injury  

Manufacturer Narrative

Additional product code hto.Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is jnj representative.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing 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.

Event Description

Device report from (b)(6) reports an event as follows: it was reported on (b)(6) 2020 that the patient underwent for an unknown surgery.During the surgery, the implant head broke away from ria tube assembly and noticed that 4x pieces of metal lost into the patient im canal.It was unknown if the surgery completed successfully.The patient outcome is unknown.Concomitant device reported: unknown ria tube assembly (part #: unknown, lot #: unknown, quantity: 1).This complaint involves one (1) device.This report is for (1) advanced appl inner shaft.This is report 1 of 1 for (b)(4).

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.H3, h4, h6: part 03.404.022s, lot 46p3577: manufacturing location: supplier ¿ (b)(4)/ inspected and packaged by: monument.Release to warehouse date: march 26, 2020.Expiration date: march 01, 2030.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.H3, h6: a product investigation was completed: all four (4) holding prongs are broken off from the received reamer head, no fragments were returned for evaluation.The cuttings edges are slightly worn.Otherwise is the device in a good condition.Dimensional inspection showed the relevant dimensions were conforming.The relevant drawing was reviewed to verify the relevant dimensions, the material and the hardness specification.The review of the manufacturing documents has shown that the raw material was conforming and that the hardness was within the specification.The complaint is rated as confirmed as the holding prongs are broken off as complained.During the performed evaluation no manufacturing related issue could be detected.Based on the provided information the exact cause of this occurrence cannot be defined.It is likely that a mechanical overload during use did lead to the breakage of this device.Relevant actions have been taken to address the issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.H9: 3008812560-10/26/2020-001-c.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.

• Brand Name: 13.0MM REAMER HEAD FOR RIA 2 STERILE
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10864038
• MDR Text Key: 217123990
• Report Number: 8030965-2020-09044
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 07612334142443
• UDI-Public: (01)07612334142443
• Combination Product (y/n): N
• PMA/PMN Number: K993335
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 03.404.022S
• Device Lot Number: 46P3561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2020
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/18/2020
• Supplement Dates Manufacturer Received: 11/26/2020
• Supplement Dates FDA Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: SEE H10
• Patient Sequence Number: 1
• Treatment: UNK - RIA
• Patient Outcome(s): Required Intervention