MAUDE Adverse Event Report: ORTHO DEVELOPMENT FEMORAL HEAD TRIAL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 238-0031

Device Problem Fracture (1260)

Patient Problem Arthralgia (2355)

Event Type  malfunction  

Manufacturer Narrative

Date of event - user facility medwatch form received from fda states the date of event was "(b)(6) 2020" but the e-submitter software does not allow a month-year date to be entered without a day.Therefore, date of event is reported here.Lot number - no lot number reported.User facility's medwatch report that was sent to fda indicates the hospital notified the manufacturer and indicates the date was "(b)(6) 2020" (user facility).Customer complaint records have been searched without regard to date and no corresponding report was located.

Event Description

On july 14, 2020, company received a medwatch report from fda that was sent to them from (b)(6) medical center in (b)(6).Fda forwarded the report to the manufacturer.This user facility report stated: "during left total hip replacement, surgeon noticed the plastic inside the femoral head trial broke as he found a little piece of plastic.He gave everything to the scrub tech and asked to look if he got all the missing pieces.The scrub tech compared the broken head trial with the other head trials and it appears that there is still missing piece(s).Surgeon looked inside the wound but unable to locate the missing piece(s).After surgery, he looked inside the suction filter and he didn't find anything.Assumed plastic piece is retained in patient.".

• Brand Name: FEMORAL HEAD TRIAL
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper, ut
• Manufacturer (Section G): ORTHO DEVELOPMENT; 12187 s. business park drive; draper, ut
• Manufacturer Contact: drew weaver ; 12187 s. business park drive; draper, ut ; 5539991
• MDR Report Key: 10391704
• MDR Text Key: 207720967
• Report Number: 1722511-2020-00018
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 238-0031
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other