MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL PK 5.5MM W/ UB2-BL UTP CBRD; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72203984
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Event or Problem Description
It was reported that during a shoulder surgery the healicoil implant broke while the surgeon was putting the implant into the humeral head using a mallet.It is unknown if there was a significant delay during the procedure.A backup device was available.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A visual inspection revealed the device was not returned with original packaging.The anchor does have debris on it.Anchor parts are still on tip of shaft.All but two anchor threads have separated from the anchor all that remains are two pieces on each side of the shaft of device.No other physical damage is visible to the device.A functional evaluation of the returned device found that mechanical portion of the device does work.Device passed all functional tests.A complaint history review concluded this was an isolated event.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate a review of the material found there are requirements for conformance and a certificate of material analysis is required based on the condition of the product material found during visual inspection it was determined that additional material testing is not required.Conclusion: without the requested clinical information or the device the root cause of the implant breakage cannot be determined.However, we cannot rule out a procedural vs user error as the likely root cause of the reported event.The retained piece of the broken anchor is implantable; however, we cannot rule out the possibility of local tissue irritation, micro-motion/and or migration of the retained broken anchor.The ifu for healicoil warns: the use of excessive force during insertion can cause failure of the suture anchor or insertion device.Per communications, a backup device was available, there was no significant delay or other complications reported.Therefore, no further clinical/medical assessment is warranted at this time.It was determined the device did not contribute to the reported event.The complaint was confirmed.Factors, which could have contributed to the complaint event, include an application of unintended inappropriate or excessive force to the device.No containment or corrective actions are recommended at this time.

• Brand Name: HEALICOIL PK 5.5MM W/ UB2-BL UTP CBRD
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 10945553
• Report Number: 1219602-2020-01985
• Device Sequence Number: 3190072
• Product Code: MBI
• UDI-Device Identifier: 00885554032116
• UDI-Public: 00885554032116
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K113294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/06/2023
• Device Model Number: 72203984
• Device Catalogue Number: 72203984
• Device Lot Number: 50751203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2020
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2018
• 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