MAUDE Adverse Event Report: SYNTHES GMBH 2.8 GUIDE WIRE FLUTES 300/150 CALIB; WIRE, SURGICAL

Catalog Number	292.81
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Additional 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d2b: additional product code: hty.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: 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 or Problem Description
It was reported that on (b)(6) 2023, during an ankle fusion, a 2.8 wire was stuck in a 7.3 cannulated screw that was removed because it was too long.The wire was removed from the inside of the screw.During the case, the surgeon needed a 55mm or 60mm fully threaded cancellous screw, however they were missing from the set.The surgeon ultimately decided to use a 7.3 cannulated screw successfully.The surgeon had issues seating a screw down all the way because it may have been interfering with another screw.The screw was shortened and inserted, but did not have a great purchase.The surgeon decided to insert another screw from a different point that had better purchase.This patient had some existing stryker hardware implanted.Additionally, it was noticed that there were 6.5 cannulated screws in the 7.3 cannulated caddy.Sales consultant had a conversation with spd for them to check their screw caddies to ensure the screws were correct.The surgeon attempted to place a screw in between the stryker screws, and had issues passing the screw, so had to reposition the wire and the screw was successfully passed, but possibly in contact with the stryker screws.Sales consultant asked the surgeon what type of metal the stryker screws were, to which he thought titanium.Sales consultant let him know ours were stainless still and our stance on not recommending that screws of different metals contact.He mentioned in theory it would be a problem, but he wasn't concerned about this fixation.No other information is available.There was a surgical delay of 10 minutes.The procedure was completed successfully.There was no patient consequences.This report is for one (1) 2.8 guide wire flutes 300/150 calib.This is report 3 of 3 for complaint (b)(4).

• Brand Name: 2.8 GUIDE WIRE FLUTES 300/150 CALIB
• Common Device Name: WIRE, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17794303
• Report Number: 8030965-2023-11979
• Device Sequence Number: 15326210
• Product Code: LRN
• UDI-Device Identifier: 10886982180995
• UDI-Public: (01)10886982180995
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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: 292.81
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2023
• Supplement Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 7.3MM CANNULATED SCREW 32MM THREAD/60MM; 7.3MM CANNULATED SCREW 32MM THREAD/65MM; 7.3MM CANNULATED SCREW 32MM THREAD/90MM; UNK - SCREWS: 6.5 MM CANNULATED; UNK - SCREWS: 6.5 MM CANNULATED; UNK - SCREWS: CANCELLOUS; UNK - SCREWS: CANCELLOUS
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 95 KG