MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CRUTCH,ALUMINUM,ADULT,TALL,LF,300LB

Catalog Number MDSV80534

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/09/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported, "a patient was given crutches and the pin came out and caused the patient to fall.End user subsequently went to the emergency room (er) and x-rays taken.Email received by facility representative, haywood regional medical center, with additional information in regards to this incident.Reporter states, "mother called emergency room (er) stating her son was walking with the crutches and the plastic piece at the bottom broke causing him to fall.At the time patient had called his surgeon to notify them of the incident that occurred with the crutches to see what their recommendations were.(he had to have surgery at mission by a trauma surgeon on (b)(6) 2021, which is why he was prescribed the crutches in the first place).Patient later presented to er (b)(6) 2021 with crutches, the plastic piece that had broken while he was simply walking thru his home was duck taped." reporter states, "x-rays of "left tib/fib showed hardwire to be intact and no acute findings." per provider documentation, "patient has close follow-up with ortho surgeon at mission." sample is available for return however; at the time of this report has not been return to the manufacturer.Due to the reported incident, medical intervention and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

It was reported, "a patient was given crutches and the pin came out and caused the patient to fall.End user subsequently went to the emergency room and x-rays taken.

Manufacturer Narrative

Supplemental documentation changed/additional information added.D9: device available for evaluation yes, sample received (b)(6) 2021.G6: type of report: follow-up.H2: if follow-up what type? additional information, device evaluation.H3 device evaluated by manufacturer yes.H6: type of investigation: 10.H5: investigation conclusion: zcd00005/defect confirmed: unknown responsible party.H10: investigation report reads as follows: (b)(6) 2021 06:22:59 cst (alant) "material number: mdsv80534 sample and/or photo provided? sample (quantity provided:1 pair).Lot number? 74720010003.Defect(s) from complaint:1 each." investigation results: confirmed.Investigation conclusion/root cause: "we received 1 pair of aluminum crutches in used condition.The quality complaint indicates the customer was using the crutches in his home and one of them broke causing a fall to the floor.We did check this and can see the lower plastic base is missing the plastic pins needed to secure the lower frame to the center height adjustment tube.The under arm pads and the plastic supports under the pads are not damaged, and the handle hardware is tight and shows no damage.The bottom rubber tips and the hand grips show signs of normal wear.The frame looks straight with few scratches.Based on the condition of these crutches it is undetermined what type of maintenance has been performed.The root cause of this issue is unknown.The quality complaint has been confirmed.The sample will be held.Divisional quality assurance will continue to monitor via monthly and quarterly trending.".

Event Description

It was reported, "a patient was given crutches and the pin came out and caused the patient to fall.End user subsequently went to the emergency room and x-rays taken.

• Type of Device: CRUTCH,ALUMINUM,ADULT,TALL,LF,300LB
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11752726
• MDR Text Key: 256448192
• Report Number: 1417592-2021-00083
• Device Sequence Number: 1
• Product Code: IPR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDSV80534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Date Manufacturer Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Weight: 80