MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.5MM CORTEX SCREW SELF-TAPPING 40MM; SCREW, FIXATION, BONE

Model Number	214.840
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight is unknown.Additional product code: ktt.Device broke intra-operatively; device was not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter phone number and email address are unknown.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 synthes (b)(4) as follows: it was reported that on (b)(6) 2018, during an osteotomy procedure, the first cortical screw broken in the patient when it was implanted.Then, a drill bit part also broke and stayed in the patient.Surgical outcome was not affected, the procedure was completed successfully.There was no surgical delay.Patient outcome was not provided.Concomitant devices reported: locking compression plate (lcp) distal femur plate - less invasive stabilization system (liss) (part 222.259, lot unknown, quantity 1), 5.0 mm locking screw, self-tapping (part 212.214, lot unknown, quantity 3), 5.0 mm locking screw, self-tapping (part 212.217, lot unknown, quantity 2), 5.0 mm locking screw, self-tapping (part 212.219, lot unknown, quantity 1), 5.0 mm locking screw, self-tapping (part 212.223, lot unknown, quantity 2), 5.0 mm locking screw, self-tapping (part 212.224, lot unknown, quantity 2), 2.0 mm kirschner wire (part 212.224, lot unknown, quantity 2).This is report 1 of 2 for (b)(4).

• Brand Name: 4.5MM CORTEX SCREW SELF-TAPPING 40MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7838012
• Report Number: 8030965-2018-56115
• Device Sequence Number: 13905343
• Product Code: HWC
• UDI-Device Identifier: 10886982154699
• UDI-Public: (01)10886982154699
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K112583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/16/2018

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 Model Number: 214.840
• Device Catalogue Number: 214.840
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 08/31/2018
• Patient Sequence Number: 1
• Patient Age: 38 YR