MAUDE Adverse Event Report: SYNTHES GMBH 7.3MM CANNULATED SCFE SCREW 10MM THREAD/60MM; SCREW, FIXATION, BONE

Catalog Number	02.207.603
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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: e3: initial reporter is a synthes employee.Part # 02.207.603 synthes lot # h709200 supplier lot # n/a release to warehouse date: 20 sep 2018 manufactured by: synthes monument.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.The overall complaint was confirmed as the scfe screw is over 5 mm longer than what the product code etched on it should be.The legal manufacturer was notified and performed a photo investigation.An investigation was raised by mark two engineering and it was found that the scfe screw was likely manufactured as part #: 02.207.604.The previous batch of screws manufactured before lot: h709200 (60mm screws) was h709205 (65mm screws), with 49 conforming and 1 rejected screw.This rejected screw somehow made its way into lot: 4709200 (60 mm screws) and was released by mark two engineering to monument.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
Device report from colombia reports an event as follows: it was reported that on an unknown date during equipment inspection, the screw in question was found to be longer than intended.The 60 mm length was measured having a length of 65 mm.There was no reported patient or procedure involvement.This report is for a 7.3mm cannulated scfe screw 10mm thread/60mm.This is report 1 of 1 for (b)(4).

• Brand Name: 7.3MM CANNULATED SCFE SCREW 10MM THREAD/60MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18449548
• Report Number: 8030965-2024-00281
• Device Sequence Number: 7632974
• Product Code: HWC
• UDI-Device Identifier: 10886982052322
• UDI-Public: (01)10886982052322
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K092909
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 02.207.603
• Device Lot Number: H709200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown