MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SPEED COMPRESSION IMPLANT KIT 18X18X18MM; STAPLE, FIXATION, BONE

Model Number	SE-1818
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.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
Device report from synthes reports an event in (b)(6) as follows: it was reported during a left midfoot fusion with a repair of peroneal tendon with bone graft, the compression implant had loosened from insertion handle during transport and fully detached while the box was being opened.The implant was unable to be inserted as compression had already initiated upon release from handle, meaning it would no longer match up to the pre-drilled holes.Patient status and surgical delay was unknown.This is report 1 of 1 (b)(4).

• Brand Name: SPEED COMPRESSION IMPLANT KIT 18X18X18MM
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9884436
• Report Number: 8030965-2020-02316
• Device Sequence Number: 16724605
• Product Code: JDR
• UDI-Device Identifier: 00810633020197
• UDI-Public: (01)00810633020197
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K142292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2020

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: SE-1818
• Device Catalogue Number: SE-1818
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 03/26/2020
• Patient Sequence Number: 1