MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC PEEK-OPTIMA ANCHOR 2.7MM GRAVITY SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	86PK2027
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During insertion, the lower half of the anchor broke off.The complaint product cannot be returned, and no images are available.The procedure was driven by the clinical reasons of ankle instability and debridement.There were no medical interventions or surgical delays, and no additional adverse events.Debris were noted during the procedure.However, not all debris could be removed from the patient or surgical field, as the other half of the anchor inserted into the bone could not be obtained.The issue was resolved by utilizing another anchor.
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.H3 other text : half of the device was discarded and the other half remains in the bone.
Event or Problem Description
During insertion, the lower half of the anchor broke off.The complaint product cannot be returned, and no images are available.The procedure was driven by the clinical reasons of ankle instability and debridement.There were no medical interventions or surgical delays, and no additional adverse events.Debris were noted during the procedure.However, not all debris could be removed from the patient or surgical field, as the other half of the anchor inserted into the bone could not be obtained.The issue was resolved by utilizing another anchor.
Additional Manufacturer Narrative
Please note the correction made to the d5 operator of device: the reported event was not confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.

• Brand Name: PEEK-OPTIMA ANCHOR 2.7MM GRAVITY SUTURE ANCHOR
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17542602
• Report Number: 3010667733-2023-00438
• Device Sequence Number: 17775848
• Product Code: MBI
• UDI-Device Identifier: 00840420193711
• UDI-Public: 00840420193711
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K170265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2023

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 Catalogue Number: 86PK2027
• Device Lot Number: 1706478
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2023
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2022
• 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