MAUDE Adverse Event Report: ARTHROCARE CORP. 6.5MM PUNCH TAP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	OM-9820
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during a rotator cuff repair case with a healicoil knotless self-tapping anchor, a punch tap was used to prepare the bone hole.However, halfway through the preparation, the tip snapped and remained lodged in the bone.An additional bone hole was needed to use the anchor.It is unknown if there was a delay, no patient injury or further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference : (b)(4).H10 h3, h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was a relationship found between the subject device and the reported incident.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.A complaint history review concluded this was an isolated event.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 review of risk management files found that the reported failure was documented appropriately.A review of the customer provided x-ray shows the broken tip of the punch tap device in the bone.A clinical review states the provided undated, unlabeled x-ray revealed the broken punch tab tip was retained in the bone.However, the root cause of the reported punch tab tip breakage cannot be determined.Per the complaint, the non-implantable punch tab tip was retained in the patient¿s hard bone, therefore, micro-motion and/or migration is unlikely.Based on the information provided, the surgeon made an additional bone hole to complete the surgery.However, it is unknown is there was a delay in the procedure.Since there was no patient harm or other complications reported, no further clinical/medical assessment is warranted at this time.The complaint was confirmed.Factors that could have contributed to the reported event include: (1) excessive force.No containment or corrective actions are recommended at this time.

• Brand Name: 6.5MM PUNCH TAP
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 12155633
• Report Number: 3006524618-2021-00758
• Device Sequence Number: 17297218
• Product Code: LXH
• UDI-Device Identifier: 00817470002584
• UDI-Public: 00817470002584
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021

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 Model Number: OM-9820
• Device Catalogue Number: OM-9820
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 07/12/2021
• Supplement Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other