MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL RG DILATOR 5.5MM REUSABLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	72203710
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after the sterilization process the handle of the healicoil regenesorb 5.5mm threaded dilator, was cracked and there was a bad smelling of the handle in the whole room.No case was involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: the reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of the customer provided image reveals a crack along the proximal end the handle.A visual inspection revealed the device was received with a fractured handle.The back hammer plate was fractured from the handle and the distal end of the handle was shattered at the shaft.The device has been worn from use.The complaint was confirmed and the root cause was associated with a component failure.Factors that could have contributed to the failure include excessive use or inappropriate force to the device.No containment or corrective actions are recommended at this time.

• Brand Name: HEALICOIL RG DILATOR 5.5MM REUSABLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10694724
• Report Number: 1219602-2020-01603
• Device Sequence Number: 11745763
• Product Code: LXH
• UDI-Device Identifier: 00885554030877
• UDI-Public: 00885554030877
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2021

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: 72203710
• Device Catalogue Number: 72203710
• Device Lot Number: 50639148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Initial Date Received by Manufacturer: 09/23/2020
• Supplement Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 10/18/2020
• Supplement Report FDA Received Date: 10/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1