MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DEPTH GAUGE FOR 1.8MM PEGS/2.4MM SCREWS; PLATE, FIXATION, BONE

Model Number	71158072
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, the depth gauge for 1.8mm pegs/2.4mm screws tip was missing.As this was noticed during field inspection, no case involved; therefore, there was no patient involvement.
Additional Manufacturer Narrative
H6: the device, used for treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms the data presented in the literature review article indicates that a patient required postoperative abt (allogeneic blood transfusion) due to preoperative anemia.Without clinically relevant patient-specific supporting documentation a thorough medical investigation cannot be performed, and the patient outcome beyond that which is documented in the article cannot be confirmed.Therefore, no further clinical assessment is warranted at this time.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: DEPTH GAUGE FOR 1.8MM PEGS/2.4MM SCREWS
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11860071
• Report Number: 1020279-2021-04518
• Device Sequence Number: 4016682
• Product Code: HRS
• UDI-Device Identifier: 00885556631720
• UDI-Public: 00885556631720
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2021

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 Model Number: 71158072
• Device Catalogue Number: 71158072
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1