MAUDE Adverse Event Report: SYNTHES GMBH DRILL BIT Ø2.5 L110/85 2FLUTE F/QUICK CO; INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT

Catalog Number 310.250

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Foreign Body Reaction (1868); Unspecified Infection (1930); Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: reporter is a j&j employee.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in columbia as follows: it was reported that a 34 year old patient male complaining of right hip pain for several years underwent total hip in another hospital complicated by infection.Came to imc diagnosed with infection and inflammatory reaction due to internal joint prosthesis and underwent removal of failed arthroplasty, debridement, and introduction of spacer.Towards the end of the surgery an x-ray of the femur was taken and it was found out that there is a broken drill bit inside the intramedullary canal of the femur.The surgeon estimated 4 hours spent on the case plus another 1 hour to remove the broken drill bit because of the very narrow intramedullary canal and since patient will go back again to do the revision total hip, the surgeon preferred to leave the removal until he does the total hip.On the 18th patient had revision of total hip arthroplasty over the right side.During this time the tip of the broken drill bit was removed using the x-ray from the medullary canal.The surgery went uneventful without any complication and patient tolerated well the procedure.Patient was followed by physiotherapy post op and was discharged on non- weight bearing ambulation.This report is for one (1) drill bit ø2.5 l110/85 2flute f/quick co this is report 1 of 1 for complaint.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Does not meet the definition of a complaint.Information has been reviewed and determined that there is no allegation of deficiency related to the identity, quality, durability, reliability, safety, effectiveness or performance of a depuy device after it was released for distribution.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was a two stages total hip revision, they removed implants first time because of infection and put spacers , later on during removal of spacers they used drill bitt 2.5 mm to remove the cement spacers which was broken then , also head of that the drill bitt has been in the hospital for over 6 years.

• Brand Name: DRILL BIT Ø2.5 L110/85 2FLUTE F/QUICK CO
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15537678
• MDR Text Key: 301113957
• Report Number: 8030965-2022-07820
• Device Sequence Number: 1
• Product Code: HSZ
• UDI-Device Identifier: 07611819018631
• UDI-Public: (01)07611819018631
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 310.250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2022
• 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): Required Intervention
• Patient Age: 34 YR
• Patient Sex: Male