MAUDE Adverse Event Report: TELEFLEX LLC SKIN STAPLER 35W; STAPLER, SKIN

Model Number	25-3001
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hair Loss (1877)
Date of Event	12/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A user facility reported, "hello - i would like to report a quality issue with a deroyal product.I recently switched products to deroyal for staples in the scalp during surgery.I have now had four instances of a severe alopecia areata or inflammatory alopecia like reaction around the staples which i have never seen before with any staples.They all appear to be from the same lot number and time frame.All i can think of is that perhaps there is something in the coating of the staples.The lot number is 73b2300556.Ref 25-3001." this mdr represents one of the four instances described above.This is complaint 4 of 4.A supplier corrective action request (scar) has been sent to the supplier, teleflex llc.This investigation is not complete at this time.No further information is available at this time.We will providie follow-up report when additional information becomes available.
Event or Problem Description
A user facility reported, "hello - i would like to report a quality issue with a deroyal product.I recently switched products to deroyal for staples in the scalp during surgery.I have now had four instances of a severe alopecia areata or inflammatory alopecia like reaction around the staples which i have never seen before with any staples.They all appear to be from the same lot number and time frame.All i can think of is that perhaps there is something in the coating of the staples.The lot number is 73b2300556.Ref 25-3001.".
Additional Manufacturer Narrative
A user facility reported, "hello - i would like to report a quality issue with a deroyal product.I recently switched products to deroyal for staples in the scalp during surgery.I have now had four instances of a severe alopecia areata or inflammatory alopecia like reaction around the staples which i have never seen before with any staples.They all appear to be from the same lot number and time frame.All i can think of is that perhaps there is something in the coating of the staples.The lot number is 73b2300556.Ref (b)(4)." this mdr represents one of the four instances described above.This is complaint 4 of 4.A supplier corrective action request (scar) has been sent to the supplier, (b)(4).A sample from the same lot was returned to deroyal on (b)(6) 2024 and shipped to (b)(4) for testing.Teleflex performed biocompatibility testing per iso 10993-17 on the returned sample from the same lot.All biocompatibility testing passed, and no defects were found.Deroyal industries reviewed purchase orders and corrective and preventive actions relevant to this information and no issues were identified.A complaint to sales ratio was calculated from (b)(6) 2021 to (b)(6) 2023 and found to be (b)(4).Root cause: because no manufacturing issues could be found and biocompatibility testing passed, no root cause could be determined.Corrective and preventive actions: because no root cause could be determined, no corrective or preventive actions were taken.Deroyal will continue to monitor for trends around this item and issue.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: SKIN STAPLER 35W
• Common Device Name: STAPLER, SKIN
• Manufacturer (Section D): TELEFLEX LLC; 2917 weck drive; durham NC 27709 0186
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1703 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: reagan newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 19951732
• Report Number: 1060680-2023-00019
• Device Sequence Number: 8784818
• Product Code: QQS
• UDI-Device Identifier: 50749756024377
• UDI-Public: 50749756024377
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 25-3001
• Device Lot Number: 73B2300556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Other
• Patient Sex: Unknown