MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC SALVATION MIDFOOT NAIL; SCREW, FIXATION, BONE

Catalog Number	SMN10008
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported via a medwatch form that the surgeon used device to place an 80mm nail into patient's left calcaneus.Adapter broke off into two pieces into patient wound.Surgeon used a second device of same kind, it was broke into 1 piece.Attempts to remove 3 broken pieces, only able to remove 1 of 3 pieces, broken pieces left in the patient.Risk outweighed the benefits of removal.Patient was made aware of the event.
Additional Manufacturer Narrative
Received on medwatch user facility (b)(4).Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported via a medwatch form that the surgeon used device to place an 80mm nail into patient's left calcaneus.Adapter broke off into two pieces into patient wound.Surgeon used a second device of same kind, it was broke into 1 piece.Attempts to remove 3 broken pieces, only able to remove 1 of 3 pieces, broken pieces left in the patient.Risk outweighed the benefits of removal.Patient was made aware of the event.
Additional Manufacturer Narrative
The reported event could not be 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.The current instructions for cleaning, sterilization, inspection and maintenance state, "inspect devices immediately upon removal from the patient for any signs of breakage or fragmentation.If the device is damaged, retain it to assist with wright¿s analysis of the event.Carefully consider and discuss with the patient (if possible) the risks and benefits of retrieving vs.Leaving the fragment in the patient.Advise the patient of the nature and safety of unretrieved device fragments including the following information: a.The material composition of the fragment (if known); b.The size of the fragment (if known); c.The location of the fragment; d.The potential mechanisms for injury, e.G.Migration, infection; e.Procedures or treatments that should be avoided such as mri exams in the case of metallic fragments.This may help to reduce the possibility of a serious injury from the fragment." 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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: SALVATION MIDFOOT NAIL
• Common Device Name: SCREW, FIXATION, BONE
• 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: 14115583
• Report Number: 3010667733-2022-00157
• Device Sequence Number: 20316347
• Product Code: HWC
• UDI-Device Identifier: 00840420194817
• UDI-Public: 00840420194817
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2022

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 Catalogue Number: SMN10008
• Device Lot Number: 2379214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2022
• Supplement Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Unknown