MAUDE Adverse Event Report: HAGENDORF SYNTHES PRODUKTIONS GMBH 2.4 CORTEX SCREW SLF-TPNG T8 SD REC 16; SCREW, FIXATION, BONE

Model Number	201.766
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
Additional narrative: the complaint condition was confirmed for the 2.4 cortex screw slf-tpng t8 sd rec 16 (p/n: 201.766, lot #: 97p3737).The process sheet that should have been used is ps069521 rev.C for part 201.766 that was after reviewing the work orders there is evidence that the same two operators processed all three orders using machine 1147 and produced from the same raw material and all the parts were produced on line l.The operators used the wrong revision of the process sheet and may have manually keyed in the incorrect part number.Machine 1147 does not keep a log or report that could be checked.The actual part manufactured was 212.816/ vs208.016 - cortscr 2.4 self-tap l16 sst vs.The complaint screw part 201.766-us cortscr 2.4 self-tap l16 sst.It is unclear how this nonconformance was not detected during inspection verifications and additional investigation will be documented additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot : manufacturing location: (b)(4).Manufacturing date: 26-mar-2021 part number: 201.766, 2.4mm cortex screw slf-tpng with t8 stardrive recess 16mm lot number: 97p3737 (non-sterile) component part(s) reviewed: part number: 02.211.115.999, 2.8mm sec screw blank 19mm no head turn/no point w/sd8 lot number: 94p0653 this lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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 an unknown date, received replenishment orders for field set and two packages contained the wrong screws.No patient involvement, this report is for one (1) 2.4 cortex screw slf-tpng t8 sd rec 16.This is report 1 of 1 for (b)(4).

• Brand Name: 2.4 CORTEX SCREW SLF-TPNG T8 SD REC 16
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): HAGENDORF SYNTHES PRODUKTIONS GMBH; im bifang 6; hagendorf 4614 ; SZ 4614
• MDR Report Key: 12091916
• Report Number: 8030965-2021-05443
• Device Sequence Number: 3960177
• Product Code: HWC
• UDI-Device Identifier: 10886982142764
• UDI-Public: (01)10886982142764
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K112583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2021

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: 201.766
• Device Catalogue Number: 201.766
• Device Lot Number: 97P3737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 06/30/2021
• Patient Sequence Number: 1